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. Trials are usually done in three parts or "phases".
Open Trials
Sponsor: Department of Defense/University of Miami
Title:DCM II Trial
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.
Additional details can be found on the study website: www.dcmii.org
More information regarding this trial is at www.clinicaltrials.gov
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%.
Study Duration: 3 years (including one year of in-person participation)
Principal Investigator: Phillip Yang MD
Study Lead: Fouzia Khan (650-736-1410) & Ashwini Narayana (650-721-6092)
Sponsor: NIH
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: Array
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
Study Lead: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Sponsor: Myokardia
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
More info on ClinicalTrials.gov
Study Lead: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Sponsor: Novartis
Protocol: CLCZ696I12201
Title: A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)
Details: 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 oftreatment. LCZ969 (Entresto®) is being used off label for this
study toevaluate improving exercise capacity. This study will also explorechanges in cardiac structure and function
(LV mass,LV wall- thicknessand NT-proBNP) following treatment with LCZ696 (Entresto) in thispatient population. '
Who might be eligible: Subjects with non-obstructive HCM
Study Duration: Approximately 1 year
Study Lead: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Sponsor: Salubris
Protocol: JK07.1.01
Title: A Randomized, Double-Blind, Placebo-controlled, Single-ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of JK07 in Subjects with Heart Failure with Reduced Ejection Fraction (HFrEF)
Details:
The main purpose of the study is to evaluate the safety and activity of
the investigational product in subjects with heart failure who have a lower
than normal amount of blood pumped by the heart (weaker hearts). This study is
a “first-in-human” study of the protein JK07 and will determine if, and at what
dose, this product is safe and tolerable, how long it stays in your body, and
whether it has any effect on your heart function. This study could lead to further
and future studies of this product in larger patient populations. JK07 is a
protein which was designed to stimulate your heart in a way that promotes
regeneration and better functioning, including increasing the amount of blood that
your heart pumps (stronger hearts).
Initially 5 cohorts are planned with the option to expand the study to a total of 7
cohorts. The size of the cohorts will range from 5 to 9 subjects. Each
cohort will include one single active unblinded sentinel subject receiving a single
IV dose of JK07 prior to randomized JK07 or placebo administration in the
remainder of the cohort.
Who might be eligible: Subjects with heart failure with reduced ejection fraction (£ 40%)
Study Duration: Approximately 6 months
Study Lead: Dr. Matthew Wheeler
Contact: jennckim@stanford.edu
Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program
This study seeks to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in a population of South Asian patients who have low to moderate cardiovascular disease (CVD) risk by traditional risk scoring.
Who might be eligible: South Asian patients 18 years or older who are not taking cholesterol-lowering medication or cholesterol-lowering supplements and have an LDL-C level of 120-189mg/dl and an ASCVD Risk score <7.5%. Patients with a LDL-C > 189 mg/dl and an ASCVD Risk score >7.5%, who are deemed intolerant of statins or who refuse lipid lowering medication, may also qualify for the study.
Study Duration: 3 months
Study Lead: Destini Gibbs-Curtis CRC- Email: dgc552@stanford.edu
PI: Rajesh Dash, MD PhD
More information on ClinicalTrials.gov ( NCT04030247)
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
PI : Dr. Joshua Knowles
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
RELIEVE-HF TRIAL: Reducing Lung congestIon symptoms using the v-wave shunt in advanced Heart Failure
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.
Who might be eligible: The type of participants will be male and female subjects , ≥18 years of age with a diagnosis of NYHA functional class III or ambulatory class IV HF irrespective of left
ventricular ejection fraction, who have a history of hospitalization for worsening HF or BMI corrected elevated levels of BNP/NT-proBNP, in the setting of guideline-directed HF medical (including drug and device) therapy (GDMT).
Study Duration: Approximately 9 years
Study Lead: Pragya Tripathi - Email: pragyat@stanford.edu
PI : Dr. Jeffrey Teuteberg
Studypages Information: https://studypages.com/s/do-you-have-heart-failure-consider-participation-in-a-research-study-872429/
More information on ClinicalTrials.gov : NCT03499236
Pilot Study for evaluation of ezCVP in heart failure patient
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.
Who might be eligible: The patients ,who are admitted to inpatient heart failure service requiring diuretics therapy, and the study device is intended to improve care of heart failure patients.
Study Duration: Approximately 3 months
Study Lead: Pragya Tripathi - Email: pragyat@stanford.edu
PI : Dr. Michael Fowler
More information on ClinicalTrials.gov : N/A as this is a pilot study.
Sponsor: BioCardia Inc.
CardiAMP Cell Therapy HF Trial
A randomized controlled pivotal trial of autologous bone marrow mononuclear cells using the cardiAMP cell therapy in patients with post myocardial infarction Heart Failure.
The CardiAMP heart failure trial is studying an investigational stem cell-based therapy for heart failure that develops after a heart attack.
The therapy takes a personalized and minimally-invasive approach to the use of a patient’s own cells in the treatment
of ischemic heart failure, and is designed to stimulate the body’s natural healing response. The study participants will be
randomly placed into one of two groups, a treatment and a sham control group.
Who might be eligible: Patients between the ages of 21 and 90, diagnosed with NYHA Class II or III heart failure as a
result of a previous heart attack, and have a Left Ventricular Ejection Fraction of the heart between 20% and 40%.
Study Duration: 2 years
Principal Investigator: Phillip Yang MD
Study Lead: Fouzia Khan (650-736-1410) & Ashwini Narayana (650-721-6092)
Sponsor: AiCare Inc.
ACT Trial:
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 above the age of 21, recently admitted to any CV units, and are about to be discharged.
Study Duration: 30 days
Principal Investigator: Jeffery Teuteberg MD
Study Lead: Banu Priya Rajasekaran (650-721-6092)
Clinicaltrials.gov information to be added soon.
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: Sujatha Kalle CRC email: skalle@stanford.edu
More info on clinicaltrials.gov. NCT# - NCT03507777
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 is 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.
Study PI: David Patrick Lee MD
Study lead: Maria Perlas CRC email: mperlas@stanford.edu
More info on clinicaltrials.gov. NCT# - NCT03309332
https://clinicaltrials.gov/ct2/show/NCT03309332?term=amplatzer&draw=2&rank=3
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 is eligible:
· 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.
Study PI: David Patrick Lee MD
Study lead: Maria Perlas CRC email: mperlas@stanford.edu
More info on clinicaltrials.gov. NCT# - NCT04060641
https://clinicaltrials.gov/ct2/show/NCT04060641?term=geneticure&draw=2&rank=3
CT-CABG: Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery
Sponsor: NHLBI
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.
Study Lead: Nisha Udupa (nishaudupa@stanford.edu)
PI: Dr. Koen Nieman
More information on ClinicalTrials.gov : NCT03894423
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.
Study Lead: Nisha Udupa (nishaudupa@stanford.edu)
PI: Dr. Koen Nieman
More information on ClinicalTrials.gov : NCT04424030
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORIAN-PLAQUE)
Sponsor: Novartis Pharmaceuticals
The purpose of this research study is to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24.
Who might be eligible: This research study is looking for patients with non-obstructive coronary artery disease, where coronary arteries are blocked less than 50%, with no previous cardiovascular events who meet additional eligibility criteria.
Study Duration: 2 years including 2 CT scans and 6 study visits to receive study medication.
Study Lead: Nisha Udupa (nishaudupa@stanford.edu)
PI: Dr. Koen Nieman
More information on ClinicalTrials.gov : NCT05360446
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: Patients between the ages of 21 - 80 with chronic ischemic left ventricular dysfunction secondary to myocardial infarction(LVEF <40%), been treated with appropriate maximal medical therapy for heart failure, and a candidate for cardiac catheterization within 5 to 10 weeks of screening.
Principal Investigators: Phillip Yang MD, Joseph Wu MD, PhD
Contact: Fouzia Khan, MBBS Clinical Study Manager, fouziak@stanford.edu, Ph:650-736-1410
Ashwini Narayana, MBBS, Clinical Study Coordinator, ashwinil@stanford.edu, Ph:650-721-6092
Clinical Trials
