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:  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

More info on ClinicalTrials.gov


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

More info on ClinicalTrials.gov


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

More info on ClinicalTrials.gov


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

More info on ClinicalTrials.gov


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

More information on ClinicalTrials.gov : NCT03814187


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 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) & Banu Priya Rajasekaran (650-721-6092)

https://clinicaltrials.gov/ct2/show/NCT02438306


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

https://clinicaltrials.gov/show/NCT03507777s


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