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
Study Name: AGENT DCB STANCE
Use of Agent DCB Stance to treat de novo coronary lesions
Who might be eligible:
Patients above 18 years of age, diagnosed with coronary artery disease, which is a narrowing of 1 or more blood vessels that supply blood and oxygen to the heart (coronary arteries).
Principle Investigators: Dr. Jennifer Tremmel
Contact: Amarissa Joy Ramos
Email: aramos23@stanford.edu
NCT#: NCT06959524
Study Name: PREVAIL
If your doctor recommends that you get an angioplasty – a procedure to open narrow coronary arteries you can particpate in a study where you can be treated with one of two drug coated balloons (DCB):
• The Medtronic Prevail™ Paclitaxel-coated PTCA Balloon Catheter (Prevail DCB) being used in this study is investigational because it has not been approved by the U.S. Food and Drug Administration (FDA).
• The Boston Scientific Agent™ Drug-Coated Balloon (Agent DCB) is approved by the FDA. The Agent DCB is given as standard of care.
The purpose of this study is to evaluate the clinical safety and efficacy of the Prevail DCB in 1) the treatment of in-stent restenosis (ISR) which is characterized by narrowing of arteries previously treated with stents and, 2) in new narrowing of arteries in small vessels.
Who might be eligible:
You have documented chest pain (stable or unsable angina), due to disease in a small coronary vessel or in-stent restenosis, and your doctor has recommended angiolasty
Principle Investigators: Dr. Jennifer Tremmel
Contact: Amarissa Joy Ramos
Email: aramos23@stanford.edu
NCT#: NCT06535854
Study Name: OPTIMAL MicroRNA
We hope to investigate whether circulating miRs can be used to characterize the overall immune state in heart transplant patients and predict patients that may go on to develop infection and rejection.
If you agree to participate in this research study you will be enrolled into the study approximately 1 month after heart transplantation. Research samples will be collected and used to evaluate microRNA (miRs) as well as other biomarkers related to heart transplantation and immunosuppression medications.
Who might be eligible:
Inclusion Criteria: Prospective patients must meet all the following selection criteria to be eligible for participation in the study:
1) Age ≥ 18 years at time of enrollment
2) Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
3) Planned follow-up at the transplant center for a minimum of one-year.
4) Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.
Exclusion Criteria: Prospective patients are not eligible for the study if they meet any of the following criteria:
1) Recipient of a multi-organ transplant
2) History of prior solid organ transplant before the index heart transplant
3) Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)
4) Ongoing need for renal replacement therapy and/or dialysis
Principle Investigators: Dr. Kiran Khush
Contact: Anette Skoda
Email: askoda@stanford.edu
NCT#: NCT06939751
Study Name: COMET-HF
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death. It is hoped that omecamtiv mecarbil increases the heart’s ability to pump, but we need to learn more about its effect in patients who suffer the most from heart failure symptoms.
Who might be eligible:
Inclusion:
1. Have a history of chronic HFrEF2.
2. Are receiving oral loop diuretics
3. Have an LVEF < 30% measured within the previous 6 months
4. Patients with AFF must have an LVEF < 25%.
5. Are currently hospitalized with the primary reason of HF or had an HF event within 6 months prior to screening.
6. Have elevated natriuretic peptide levels (B-type natriuretic peptide [BNP] ≥ 300 pg/mL or NT-proBNP ≥ 1,000 pg/mL)
Exclusion:
1. Have previously received omecamtiv mecarbil2.
2. Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment
Principle Investigators: Dr. Masataka Kawana
Contact: Ashna Drost
Email: adrost@stanford.edu
Study Name: Progress CAS
This study is being done to see if the SAPIEN 3™, SAPIEN 3 Ultra™, and SAPIEN 3 Ultra RESILIA™ Transcatheter Heart Valve is beneficial for patients with moderate, calcific aortic stenosis. Your doctor has determined that you have this condition. The SAPIEN 3™, SAPIEN 3 Ultra™, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves are not approved by the Food and Drug Administration (FDA) for the treatment of moderate, calcific aortic stenosis and are considered experimental in this research.
Who might be eligible:
Moderate, calcific aortic stenosis
Principle Investigators: Dr. Alan Yeung
Contact: Josephine Widaja
Email: jowid@stanford.edu
NCT#: NCT04889872
Study Name: Salubris Renu-HF
JK07 is an experimental (investigational) study drug that is being tested for safety, tolerability and potential beneficial effects for participants with heart failure. This study tests different doses of the study drug to see what the effects are, if any, when compared to a placebo (a “dummy study drug” that looks exactly like the study drug but does not actually contain any study drug), along with the usual approved standard therapy that you are already taking. Heart failure is a long-lasting condition in which the heart is unable to pump enough blood to meet the body’s needs for blood and oxygen. The study drug, JK07, was developed to help treat heart failure.
Who might be eligible:
If you have heart Failure AND atrial Fibrillation (AFIB) or on and off AFib you may be a candidate.
Principle Investigators: Dr. Matthew Wheeler
Contact: Helen Luikart, RN
Email: luikart@stanford.edu
Study Name: 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:
Inclusion Criteria: Eligible subjects must meet the following criteria: 1) Heart or other organ transplant recipient (e.g. kidney, liver, lung) 2) Any age 3) Post-transplant malignancy diagnosis (PTLD, colon/rectal, lung, other solid organ cancer) 4) Availability of retrospective data Transplant and Cancer Study Version 5) Availability of banked biological samples (e.g., tissue, blood, biopsy) within 3 years prior to malignancy diagnosis Exclusion Criteria: 1) There are no anticipated exclusion criteria. All subjects meeting the inclusion criteria will be considered for this study
Principle Investigators: Dr. Kiran Khush
Contact: Anette Skoda
Email: askoda@stanford.edu
Study Name: Stanford Heart Transplant Data Base and 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 new heart transplant recipients
Principle Investigators: Dr. Kiran Khush
Contact: Eric Henricksen
Email: henricej@stanford.edu
Study Name: DCM II
A new and unique trial, to understand whether human mesenchymal stem cell therapy, in combination with other medicines, is safe in humans and will allow the heart to work better. Human mesenchymal stem cells (hMSCs) are a type of stem cell that can be grown from human bone marrow, in this case they are taken from a healthy donor’s bone marrow.
Who might be eligible:
INCLUSION (more information in the barcode): Men and women aged 18 to 79 years Diagnosis of Non-Ischemic Dilated Cardiomyopathy with left ventricular ejection fraction (EF) of ≤ 45%
Principle Investigators: Dr. Phil Yang
Contact: Fouzia Khan
Email: fouziak@stanford.edu
NCT#: NCT04476901
Study Name: HOPE
Heart Outcomes in Pregnancy Expectations (H.O.P.E) for Mom and Baby. Improving the care of women with known cardiovascular disease, as well as improve recognition of signs and symptoms of cardiac issues in pregnancy, with the goal of decreasing cardiovascular, pregnancy related morbidity and mortality by improving education, and multidisciplinary planning.
Who might be eligible:
Pregnant Cardiac Patients
Principle Investigators: Dr. Abha Khandelwal
Contact: Elizabeth Padilla
Email: epadilla@stanford.edu
NCT#: NCT06517628
Study Name: REBIRTH
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.
Who might be eligible:
Women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum
Principle Investigators: Dr. Abha Khandelwal
Contact: Tamara Bazouzi
Email: bazouzit@stanford.edu
NCT#: NCT05180773
Study Name: Lp(a)FRONTIERS CAVS
Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Who might be eligible:
Participants with elevated Lipoprotein (a) ≥175 nmol/L with mild-moderate aortic stenosis
Principle Investigators: Dr. Abha Khandelwal
Contact: Tamara Bazouzi
Email: bazouzit@stanford.edu
NCT#: NCT05646381
Study Name: The THRIVE Study
This study is looking for candidates who have been diagnosed with high blood pressure. The purpose of this research is to see if using a device that uses sound waves to heat up and destroy some of the nerves around the two arteries leading to your kidneys will control blood pressure as well as or better than using medication. This minimally invasive procedure of impairing the nerves surrounding a blood vessel is called Renal Denervation.
Who might be eligible:
• Age between 22 to 75 years of age
• Diagnosed with high blood pressure (hypertension) by a healthcare provider
• Willing to take home blood pressure readings at home
• Willing to temporarily stop taking their blood pressure medications under close medical supervision
• Willing to undergo a medical procedure
Principle Investigators: Dr. David Lee
Contact: Maria Perlas, RN
Email: mperlas@stanford.edu
NCT#: NCT6559891
Study Name: Spyral GEMINI Pilot Study
This study is looking for candidates who have been diagnosed with high blood pressure. The study hopes to learn if multi-organ denervation using the Gemini System is a safe and effective treatment for reducing blood pressure in people with or without high cardiovascular risk who have uncontrolled high blood pressure. The study includes participants with high blood pressure who may or may not be taking blood pressure medications.
Who might be eligible:
• Age 18 to 80 years of age
• Diagnosed with high blood pressure (hypertension) by a healthcare provider
• Willing to take home blood pressure readings at home
• If asked, willing to temporarily stop taking their blood pressure medications under close medical supervision
• Willing to undergo a medical procedure that will require an overnight hospital stay
Principle Investigators: Dr. David Lee
Contact: Maria Perlas, RN
Email: mperlas@stanford.edu
NCT#: NCT6907147
Study Name: PK Papyrus Coronary Stent
A New Treatment coronary stent device intended to treat acute coronary perforations or tears in the blood vessels of the heart to stop blood leakage during Percutaneous Coronary Intervention. FDA has approved the PK Papyrus Coronary Stent Graft System for commercial use in selected patients under a Humanitarian Device Exemption.
Who might be eligible:
Humanitarian device
Principle Investigators: Dr. David Lee
Contact: Maria Perlas, RN
Email: mperlas@stanford.edu
Clinical Trials
