Clinical Trials
There are over 60 CV Medicine Faculty engaged in a wide variety of clinical research protocols investigating new approaches to preventing and treating conditions and diseases in cardiac patients. Our clinicians are recognized internationally for research programs in cardiology, cardiovascular interventional procedures, regenerative medicine, structural heart disease, women’s health, arrhythmias, heart failure, hypertension and amyloidosis to name a few. These trials are conducted in close collaboration with scientists and physicians from many areas of expertise across Stanford University.
The CV Medicine Clinical Research Program supports Faculty to Enhance the ability to conduct clinical research.
The Program provide resources, expertise and best practices to facilitate proficient, compliant and ethical study conduct and management from protocol development to trial facilitation and post-trial assessment and reporting.
What Is a Clinical Trial?
Clinical trials are tests of drugs or medical devices to determine if they are safe to be used on humans and whether they are effective. The government requires clinical trials be conducted and evaluated before drugs are approved for human use. Before any drug or device can be administered or used by anyone, the sponsor must provide the FDA with the results of laboratory and animal research. Once approval is given the clinical trial process can begin.
Clinical trials are at the heart of all medical advances. They represent hope and the latest advancements in Cardiovascular Medicine treatment. In CV Medicine, we conduct more than 100 active clinical trials every year; from drug and device treatments to digital health solutions.
If you or your loved ones have been diagnosed with a Cardiovascular disease, you deserve to know about the latest in care. For that, we have developed a Research Registry that will allow you find active clinical trials that match your needs.
Use the QR code or the link below and complete a brief survey to add yourself to the registry.
Open Trials
Title: Spyral AFFIRM study
This study is looking for candidates who have been diagnosed with high blood pressure. The High Blood Pressure Clinical Study (also known as the SPYRAL AFFIRM Clinical Study) is investigating the safety, effectiveness, and long-term impact of the Medtronic Symplicity™ blood pressure procedure. This minimally invasive, invasive procedure calms excessively active nerves connected to the kidneys that may be contributing to your high blood pressure. The procedure is Renal Denervation and the device being used for this study is the Symplicity Spyral Renal Denervation system. You may be eligible for this clinical study that may help reduce your high blood pressure.
Who might be eligible:
- Age 18 or older
- Diagnosed with high blood pressure (hypertension) by a healthcare provider
- Office systolic blood pressure of ≥140 mmHg
- Willing to take occasional blood pressure readings at home
- Willing to undergo a medical procedure that may require a short hospital stay
Principle Investigators: Dr. David P Lee
Contact: Maria Perlas, Email: mperlas@stanford.edu
More info on ClinicalTrials.gov - Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN - Full Text View - ClinicalTrials.gov
Title: OCCLUFLEX
Looking for candidates that have had a history of prior stroke and have been diagnosed that they have an opening in your heart called a Patent Foramen Ovale (PFO). The Flex II PFO Occluder device could be beneficial to you in preventing another stroke by closing your PFO. This study compares an investigational product, the Flex II PFO Occluder device, to Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder, which are the current standard of care in preventing another stroke or death. Investigational means that the Flex II PFO Occluder device has not been approved by the United States Food and Drug Administration (FDA). The standard of care devices have been approved by the FDA. All of the PFO Occluder devices are implanted in the heart to close the PFO.
Who might be eligible:
- Patients over the age of 18 years and less than 50 years
- Cryptogenic stroke defined as a stroke of unknown cause
Principle Investigators: Dr. David P Lee
Contact: Maria Perlas, Email: mperlas@stanford.edu
More info on ClinicalTrials.gov Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion - Full Text View - ClinicalTrials.gov
Title: VICTORION-1 PREVENT
A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of Inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT). Study of Inclisiran to Prevent CV Events in Participants At Risk of Cardiovascular Disease
NCT#: NCT05739383
Who May Be Eligible
- Male or Female 40 years to 79 years of age
- Have an LDL-C greater than or equal to 70mg / dL (bad cholesterol)
- Are at a high risk of cardiovascular disease
Principle Investigator: Dr. Joshua W. Knowles
Contact: Tamara Bazouzi
- bazouzit@stanford.edu
- (650) 723 - 7024
Sponsor: Novartis Pharmaceuticals
Title: Odyssey
Double blind, Placebo controlled trial for patients with non-obstructive HCM. Study looks at the efficacy of a 52-week course of mavacamten compared to placebo on patient reported health and exercise capacity. A separate open-label extension study will be offered to all who finish their study treatment as per protocol.
NCT# NCT05582395
Who might be eligible: Participants must be 18 years old or local age of majority at the time of signing the informed consent. Participant characteristics diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines. An unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation.
Principle Investigators: Matthew Wheeler
Contact: Jenn M., jsmarino@stanford.edu
Title: The RELIEVE-HF Study
V-Wave,Ltd. is sponsoring the RELIEVE-HF Trial to evaluate the safety and how well the shunt works. Additionally, the study will look at the information obtained from the tests performed to see if patient has clinical improvement in their symptoms of heart failure. To evaluate the safety and performance of the shunt, additional testing will be done specifically for the purpose of this study, The objective of this study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from HF.
NCT# NCT03499236
Who might be eligible: Patients with ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months from baseline visit. Patients currently receiving chemotherapy or radiation therapy or if the participant has undergone cancer treatment, this must have been completed 2 years prior to enrollment.
Principle Investigators: Jeffrey Teuteberg
Contact: Archana, varchana@stanford.edu
Sponsor: V-wave ltd.
Title: Pilot Study for Evaluation of ezCVP in Heart Failure Patient (ezCVP)
Nihon Kohden is sponsoring the ezCVP Trial to evaluate the feasibility of using a non-invasive device to measure estimated central venous pressure (enclosed zone CVP: ezCVP) in heart failure patients. To evaluate the correlation between the CVP value at discharge and in follow-up clinic visit.
NCT# NCT03681210
Who might be eligible: Participants aged 18 and over with an arm circumference of 23 cm to 55 cm. Participant is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent.
Principle Investigators: Michael Fowler
Contact: Jenn M., jsmarino@stanford.edu
Sponsor: Nihon Kohden
Title: HEAL
This study is designed to investigate the response of unilateral upper extremity (arm) lymphedema to oral acebilustat. Participants will have an active enrollment of 9 months, encompassing visits to Stanford at 3-month interval. Each participant will receive a full treatment course of the active drug
NCT# NCT05203835
Who might be eligible: Male or female, ages 18-75. Chronic lymphedema of 6 months duration and an ECOG Stage 0-2. If a potential participant has undergone prior microvascular (vascular lymph node transfer, lymphaticovenous anastomosis) or debulking surgical intervention, at least one year must have elapsed prior to screening.
Principle Investigators: Stan Rockson
Contact: Shayne, shayneh@stanford.edu
Sponsor: Celltaxis, Innovative Medicine Accelerator
Trial (CardiAMP Study)
This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
NCT# NCT02438306
Who might be eligible: Patients that are greater than 21 and less than 90 years of age. A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
Principle Investigators: Phil Yang
Contact: Fouzia, fouziak@stanford.edu
Sponsor: BioCardia Inc.
Title: ACT Trial - Phase 2
Activity Assessment of Patients Discharged from Hospital. The purpose of this study is to examine the safety and feasibility of the AiCare platform to monitor in real-time, the physical activity of newly discharged patients. AiCare's platform provides 24/7 monitoring of the participant's physical activity.
Who might be eligible: Patients that are aged 18 and over. Heart failure patients, discharged from Stanford Hospital, CCU and CSU, to home.
Principle Investigators: Jeffrey Teuteberg
Contact: Fouzia, fouziak@stanford.edu
Sponsor: AiCare Inc.
Title: PCSK 9 inhibition
Phase 2, prospective, randomized, placebo-controlled, double-blind study to test the safety and efficacy of the PCSK9 inhibitor (alirocumab) on Cardiac Allograft Vasculopathy when given early after heart transplantation. The objective is to reduce the onset and progression of CAV (Coronary Artery Vasculopathy).
NCT# NCT03537742
Who might be eligible: Adults 18 years of age or older. Female patients of childbearing potential must have negative pregnancy test. De Novo Heart transplant recipient within the 8-10 weeks of Transplantation that meets eligibility.
Principle Investigators: Bill Fearon
Contact: Helen, luikart@stanford.edu
Sponsor: NIH
Title: Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program
The purpose of this study is to measure the incremental effectiveness of a twice daily plant sterol supplement in a population of South Asian patients who have low-to-moderate cardiovascular disease (CVD) risk.
NCT# NCT03681210
Who might be eligible: Subject is a male or female, 18 years of age and 61 years of age. Subject has LDL-C & 130 and & 190 mg/dL measured in the past 3 months (or measured at the baseline visit), while not taking cholesterol-lowering medication for at least 1 month prior.
Principle Investigators: Rajesh Dash
Contact: Tamara, bazouzit@stanford.edu
Sponsor: Piper Biosciences Inc.
Title: Novartis-LCZ696
The purpose of this study is to determine if LCZ696 (Entresto) is safe, tolerable and can improve exercise capacity (via improved peak VO2). In non obstructive HCM population over the course of 50 weeks of treatment. LCZ969 (Entresto®) is being used off label for this study to evaluate improving exercise capacity. This study will also explore changes in cardiac structure and function (LV mass, LV wall- thickness, and NT-proBNP) following treatment with LCZ696 (Entresto) in this patient population.
NCT# NCT04164732
Who might be eligible: Male or female and 18 years of age at the time of consent. Diagnosed with Hypertrophic Cardiomyopathy (hypertrophied and non-dilated left ventricle in the absence of any systemic cause) with a left ventricular wall thickness and 13mm by the echocardiogram obtained during the screening/baseline period, based on local evaluation of echocardiographic images.
Principle Investigators: Matthew Wheeler
Contact: Jenn M., jsmarino@stanford.edu
Sponsor: Novartis
Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb study (The Victorian-Plaque Study)
The purpose of the study is to investigate the efficacy of a drug, inclisiran, alongside traditionally used statins, on reducing the buildup of plaque in the coronary arteries. Study participants will have non-obstructive CAD and will have the change in coronary plaque measured by a cCTA scan prior to the inclisiran course, and a cCTA scan after the course. Study participants will be randomized to receive either the investigational drug or a placebo.
NCT# NCT05360446
Who might be eligible: The study will enroll participants with non-obstructive coronary artery disease. Ages 18-80 that will undergo a statin optimization period if not meeting the maximum tolerated dose criteria.
Principle Investigators: Dr. Koen Nieman
Contact: Sarah, smagee2@stanford.edu
Sponsor: Novartis
Title: Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction (HECTOR)
A first-in-human trial in the US, the HECTOR team will use human embryonic stem cell-derived cardiomyocytes that will be administered to patients at the site of the heart damage. This initial trial will evaluate the safety and feasibility of the therapy and the effect upon heart function.
NCT# NCT05068674
Who might be eligible: Participants must be 21 and 80 years of age. Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe hypokinesis. Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
Principle Investigators: Phillip Yang MD
Contact: Fouzia Khan, MBBS Clinical Study Manager, fouziak@stanford.edu
Sponsor: CIRM
Title: Heart Transplant and Cancer Risk
A better understanding of cancer risk in transplant recipients will clarify the role of the immune system, infections, and other factors in the development of cancer and could identify opportunities to improve transplant safety.
Who might be eligible: All heart transplant recipients of any age and all adult lung transplant recipients followed at LPCH/Stanford Hospital who are diagnosed with a new post-transplant malignancy of any type.
Principle Investigators: Kiran Khush
Contact: Helen, luikart@stanford.edu
Sponsor: NIH
Title: Stanford Heart transplant Data Base & Biobank
To direct research and gain insight on the improvement in heart transplant outcomes. It involves collecting your clinical information from your medical record and optional collection of occasional blood samples for future research. The registry is open to all adult heart transplant patients before, and immediately after transplantation.
The information and samples stay at Stanford.
Who might be eligible: All heart adult (age 18 years) heart transplant candidates and recipients. Heart candidate and other organ such as heart and kidney transplant recipient and heart and liver transplant recipients, or combination of heart, kidney and liver.
Principle Investigators: Jeffrey Teuteberg
Contact: Helen, luikart@stanford.edu
Title: Influence of Genes on Heart Rhythm Disorders
Who might be eligible: Study patients will be individuals undergoing EPS, ablation, or device implantation for clinically indicated electrophysiological reasons. Since this is a cross sectional study, there will be no control group.
Principle Investigators: Sanjiv Narayan
Contact: Iris, huichang@stanford.edu
Sponsor: NIH
Title: DCM II A Phase IIB, randomized, placebo-controlled, multi-center study. This is a new, unique cell therapy trial, designed to assess the efficacy and safety of delivering allogeneic human mesenchymal stem cells (allo-hMSCs) versus placebo, via trans-endocardial injection in patients with non-ischemic dilated cardiomyopathy. allo-hMSCs or placebo administered via the Biosense Webster NOGA MYOSTAR Injection Catheter System will be tested in a total of one hundred and thirty-six (136) subjects divided into six groups. As the primary aim is to establish a genetic component to subject responses, subjects will be genotyped prior to randomization. Who might be eligible: Patients between the ages of 18 and 80, diagnosed with non-ischemic dilated cardiomyopathy, and a Left Ventricular Ejection Fraction (EF) of the heart below 45%. Principle Investigators: Phillip Yang MD Contact: Fouzia Khan (650-736-1410) |
Title: Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic (PRO-HF Trial)
Details: This is a randomized study evaluating whether clinicians having a standardized questionnaire about heart failure symptoms during routine clinic visits impacts their care. Patients will be randomized to either completing a patient-reported outcome survey each visit that is shown to their heart failure clinician, or usual care in which the clinician performs the standard interview without the questionnaire. The standardized questionnaire is the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 12-question multiple-choice survey. This instrument has been shown to capture heart failure symptom severity and predict prognosis. We will evaluate whether using the KCCQ-12 during routine clinic visits impacts health status or treatment patterns at 1 year.
Who might be eligible: All adults being seen in the Stanford Heart Failure Clinic are eligible. This will capture adult patients with heart failure who may benefit from routine assessment of their heart failure-related quality of life.
Study Duration: The expected duration of enrollment is 6 months. The follow-up is 12 months. The expected total duration of the study is 24 months.
Protocol Director: Dr. Alexander Sandhu
Study Coordinator: Jaime Calma
Contact: calma3@stanford.edu
Sponsor: NIH
Protocol: ARRY-371797
Title: A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
Details: This is a randomized, double-blind, placebo-controlled study in
patients with DCM due to a LMNA mutation. The study will further evaluate a dose level of ARRY-371797 (400 mg BID) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed (all patients have had the opportunity to complete the Week 24 assessment in the randomized double-blind treatment period) and an evaluation of hospitalization-free survival (HFS; defined as time from randomization to HF-related hospitalization and all-cause mortality) has been completed, eligiblepatients may receive open-label treatment with ARRY-371797.
Who might be eligible: Symptomatic dilated cardiomyopathy patients who are Lamin A/C gene mutation positive. All study participants who have taken the study drug in the randomimzed, double-blinded phase have the opportunity to receive ARRY-371797 in the open label phase
Study Duration: Approximately 4 years
Principle Investigators: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Sponsor: Array
Title: A Prospective, Multi-Center, Randomized Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (PROACTIVE-HF Trial)
Endotronix is sponsoring the PROACTIVE-HF Trial to further confirm safety and effectiveness of the Cordella PA Sensor System when used as intended, to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient centered heart failure management.
Who might be eligible: The type of participants will be male and female subjects , ≥18 years of age with a diagnosis of NYHA Class III Heart failure. intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient centered heart failure management.
Study Duration: Approximately 3 years
Study Lead: Pragya Tripathi - Email: pragyat@stanford.edu
PI : Dr. Jeffrey Teuteberg
More information on ClinicalTrials.gov : NCT04089059
Title: ILUMIEN IV - OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
Study Objective: To demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.
- This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.
- Conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific.
- Up to 3656 randomized subjects and approximately 375 roll-in subjects will be enrolled in the clinical investigation.
Study duration: The expected duration of enrollment is approximately 2 years. The total duration of the clinical investigation is expected to be approximately 5 years.
Follow up visits: Subjects participating in this clinical investigation will be followed for 2 years.
Involves phone follow up visits at 1month, 12month and 2year from the date of enrollment.
Who is eligible: Subject must be at least 18 years of age. Must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI and stent implantation.
Study PI: William Fearon MD
Study lead: Maria Perlas
Contact: mperlas@stanford.edu
NCT# NCT03507777
Title: AMPLATZERTM PFO Occluder Post Approval Study
Study Objective: The objective of this study is to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting. The AMPLATZERTM PFO Occluder is approved by the FDA (Food and Drug Administration) for PFO closure in the United States.
Study duration: The expected duration of enrollment is 3 years. The total duration of the clinical study is expected to be 9 years.
Follow up visits: After implant, subjects will return to the clinic at 1, 6 and 12 months. Subjects will have a 2-year follow-up and annually thereafter through the 5-year follow-up via telephone.
Who might be eligible: The population for this clinical study will be patients over the age of 18 years and less than 60 years who have experienced a cryptogenic stroke diagnosed by a neurologist in the 270 days prior to consent and have a patent foramen ovale diagnosed by transesophageal echocardiogram.
Principle Investigators: David Patrick Lee MD
Study lead: Maria Perlas, mperlas@stanford.edu
NCT# NCT03309332
Title: Association between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients with Hypertension – Geneticure
Study Objective: The objective of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with Medtronic’s Symplicity Spyral™ multi-electrode renal denervation system.
Study duration: The expected duration of enrollment is approximately 2 years. The total duration of the clinical investigation is expected to be approximately 5 years.
Follow up visits: No follow up’s required. The total time to participate in the study is less than 30 minutes. Enrolled subjects will need to perform a swab of their cheeks to collect cells for DNA analysis. It can be completed at house or doctor’s office, whichever the study site has decided is most appropriate.
Who might be eligible:
- An individual currently, or has previously been, enrolled in a Medtronic clinical study utilizing the Symplicity Spyral™ multi-electrode renal denervation system.
- Adults age: 18 Years to 80 Years
- Subject received renal denervation and was included in the "feasibility cohort".
- Subject has met the primary efficacy endpoint for the Medtronic Symplicity Spyral study for the arm they were randomized to.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Principle Investigators: David Patrick Lee MD
Study Lead: Maria Perlas, mperlas@stanford.edu
NCT# NCT04060641
Title: CT-CABG: Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery
The objective of this study is to integrate noninvasively acquired anatomical and functional information to develop clinically applicable tools for meaningful per-vessel revascularization decisions. The decisions will be based on quantitative lesion-specific ischemia and viability and flow simulations. These will be based on CT anatomy enhanced with a function for prediction of hemodynamic improvement after CABG.
Who might be eligible: This research study is looking for stable patients above the age of 40 who are scheduled to undergo coronary bypass grafting who meet additional eligibility criteria.
Study Duration: 1 year including two scans and a follow up call.
Principle Investigators: Dr. Koen Nieman
Study Lead: Nisha Udupa
Contact: nishaudupa@stanford.edu
Sponsor: NHLBI
NCT# NCT03894423
Title: A Long Term Extension Trial of the Phase III Lipid-Lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C (ORION-8)
Novartis is sponsoring the Orion-8 Trial to find out what happens to LDL-C levels when inclisiran is given for a longer period of time than in the previous study. The purpose of this extension study is to evaluate the efficacy, safety, and tolerability of long-term dosing of inclisiran. This study will help to assess the safety of inclisiran and perform laboratory tests for safety and effects on blood levels (efficacy) of different types of cholesterol and other related proteins in the blood. In short, the purpose of the study is to:
Evaluate what effects (good and bad) the study drug inclisiran has on the subject and their cholesterol levels when given for a longer period of time(for up to 3 years).
Who might be eligible: This study will include male or female subjects who have completed a previous qualifying Phase III lipid-lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10) MDCO-PCS-17-08 (ORION-11), or MDCO-PCS 17-02 (ORION-5)], and fulfill the study entry criteria. The reason for using such participants is because this extension study is to find out what happens to LDL-C levels when inclisiran is given for a longer period of time than in the previous study.
Study Duration: Approximately 3 years
Study Lead: Pragya Tripathi - Email: pragyat@stanford.edu
Principle Investigators: Dr. Joshua Knowles
NCT# NCT03814187
Title: International Consortium for Multimodality Phenotyping in Adults With Non-compaction (NONCOMPACT)
Sponsor: NIH
The purpose of this research study is to identify people with increased muscle bundles in the heart (called non-compaction) who are at increased risk and might benefit from preventive measures. We will re-analyze your imaging tests, collect information from your medical file, ask questions about your health, and draw a blood sample. Half of the participants will undergo a CT scan of the heart.
Who might be eligible: This research study is looking for patients with left ventricular non-compaction cardiomyopathy as seen on a cardiac MRI who meet additional eligibility criteria.
Study Duration: 5 year including one optional scan and follow-up phone calls for the 4 following years.
Principle Investigators: Dr. Koen Nieman
Study Lead: Nisha Udupa
Contact: nishaudupa@stanford.edu
NCT# NCT04424030
Protocol: MYK-461-017 (Valor-HCM)
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy who are Eligible for Septal Reduction Therapy
Details: To evaluate the ability of mavacamten to reduce the need for Septal Reduction Therapy (SRT) in guideline eligible subjects with obstructive hypertrophic cardiomyopathy who are referred for SRT. To evaluate the persistence of the effects of mavacamten in reducing the number of SRT procedures. To evaluate the effect of mavacamten on subject symptoms, cardiac biomarkers and a hemodynamic parameter.
Study drug = mavacamten 2.5mg, 5mg, 10mgor 15mg capsule once daily vs. placebo
Who might be eligible: Subjects with obstructive HCM who are eligible and willing to undergo septal reduction therapy
Study Duration: Up to 4 years
Study Lead: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Sponsor: Myokardia
Clinical Trials
