Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).

Date Added
June 9th, 2026
PRO Number
Pro00150347
Researcher
Daniel Silverman

List of Studies

Keywords
Diabetes, Drug Studies, Heart, Kidney, Obesity
Summary

Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

The WiSE® -UP Registry (The WiSE System Utilization & Performance Registry)

Date Added
April 23rd, 2026
PRO Number
Pro00150133
Researcher
Anne Kroman

List of Studies

Keywords
Heart, Surgery
Summary

This is a post approval study for those being implanted with the WiSE System. Data will be collected from your medical records including medical history, medications, the implant procedure, and device check as well as routine follow up visits, and you will be asked to complete a questionnaire at 3 visits. Participation in this post approval registry will last about 5 years. There is a risk of loss of confidentiality.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Abbott Cephea Mitral Valve Disease Registry

Date Added
April 6th, 2026
PRO Number
Pro00149421
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart
Summary

This study is seeking subjects who have been diagnosed with and may be receiving medical treatment for mitral valve disease. The purpose of this registry is to collect data to better understand the progression of mitral valve disease and the effects of different treatments on the disease and patient health. If you agree to participate in this registry, your medical data will be collected including your medical history, certain background information, and certain test images/results. This registry will also collect information about current and future treatments for your mitral valve disease and data from future disease-related follow-up visits. Data will be collected for up to 24 months. There are no additional visits or any additional testing required for this registry.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

A Multicenter, Open-label, Long-term Extension Study for Oral Levosimendan (TNX-103)

Date Added
March 10th, 2026
PRO Number
Pro00149815
Researcher
Daniel Silverman

List of Studies

Keywords
Heart
Summary

This study will continue using the study drug levosiminden to determine if it can help people with the heart failure with preserved ejection fraction with pulmonary hypertension (HFpEF-PH). Levosimenden is an investigational drug. Investigational means that this drug is not yet approved for use in any settings outside of clinical research studies like this one. This drug is thought to assist in helping with decreasing your heart failure symptoms and increase your quality of life.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits. Some tests required include physical exams, and dispensing of study medication, bloodwork.

Institution
MUSC
Recruitment Contact
Kara Loutzenhiser
843-792-1238
loutzenh@musc.edu

Horizon 360 protocol for the Treatment of Paroxysmal Atrial Fibrillation with the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Date Added
March 10th, 2026
PRO Number
Pro00149215
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the Horizon 360 System which is investigational meaning it has not yet been approved for use by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 1 year and include up to 8 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-6846
szymankr@musc.edu

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

Date Added
February 10th, 2026
PRO Number
Pro00148898
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is being done to learn more about the study drug known as AZD0780. AZD0780 is investigational meaning it has not yet been approved for commercial uses by the Food and Drug Administration (FDA) but has been approved for use in this study. This study will evaluate the efficacy, safety and tolerability of AZD0780. AZD0780 is taken once daily by mouth. This is a randomized study which means you will be assigned by chance, like flipping a coin, and you will have a 1 in 2 chance of being assigned to the study drug or placebo. Placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your study doctor or study team will know if you are assigned to study drug or placebo.

Participation in this study will last up to 4.5 years and include up to 15 visits. Study related procedures include medical history collection, physical exams, electrocardiogram (ECG – a test that records the heart's electrical activity), questionnaire and bloodwork. There are risks related to the study drug including increased blood pressure, shortness of breath and vomiting.

Institution
MUSC
Recruitment Contact
Melissa Amitrano
843-876-5009
amitrano@musc.edu

A Phase 1 Dose Escalation Trial Evaluating an Intravenously Administered Recombinant Adeno-associated Virus Serotype rh.74 (AAVrh.74) Vector Containing the Human BCL2-associated Athanogene 3 (BAG3) Gene Coding Sequence (RP-A701, AAVrh.74-BAG3) in Subjects with Dilated Cardiomyopathy Arising from Pathogenic BAG3 Variants (BAG3-DCM)

Date Added
February 10th, 2026
PRO Number
Pro00149195
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Drug Studies, Genetics, Heart
Summary

This study is seeking participants with BAG3-associated dilated cardiomyopathy (DCM). BAG3-DCM is a rare genetic disorder. Dilated cardiomyopathy is a condition that causes the heart to have a harder time pumping blood to the rest of the body which can lead to heart failure. Current treatment for BAG3-DCM is focused on improving heart function and preventing advanced heart failure with medicines, procedures and devices.

This study involves gene therapy. This will be the first time that a BAG3 gene containing study drug will be tested in human volunteers. The purpose of this research is to learn whether the investigational gene therapy RP-A701 is safe and effective for patients with BAG3-DCM. Gene therapy involves the addition of one or more genes to your cells to replace a missing gene or correct malfunctioning genes. Investigational means it is not currently approved by the Food and Drug Administration (FDA). RP-A701 will be given as a one time infusion into a vein in your arm.

Participation in this study will last about 2 years and include at least 18 visits including an inpatient hospitalization stay of at least 5 days. Study related procedures include review of your medical records, study drug infusion, immunosuppressant and antibiotic medications, echocardiogram (ultrasound test of your heart) exercise testing, electrocardiogram (recording of your heart's electrical activity), heart biopsy (collecting a piece of heart tissue), cardiac MRI, questionnaires, heart rhythm monitoring and ICD interrogations, and collection of blood, saliva, urine and stool collection. Study related risks related to gene therapy and those related to study procedures including risks of the heart catheterization, radiation, and biopsy, exercise testing, blood draw risks, genetic testing risks, the risk of loss of confidentiality and unknown risks.

Institution
MUSC
Recruitment Contact
Clara Andrews
843-876-5011
andrewcl@musc.edu

Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Date Added
January 13th, 2026
PRO Number
Pro00148538
Researcher
Bishnu Dhakal

List of Studies

Keywords
Heart
Summary

This study is evaluating the use of a new technique in ablation of ventricular tachycardia. During a heart procedure called an ablation, doctors must map the heart to find the small areas causing the abnormal rhythm. The study compares two different mapping methods: the standard high-density voltage mapping and a newer method called ILAM, which may help doctors find the problem areas more quickly and precisely. If you join the study, you will be randomly placed—like flipping a coin—into one of the two mapping groups during your procedure. Both methods are already FDA-approved and used for treating VT. You will also have several follow-up visits over 12 months so the study team can check your heart rhythm, device activity (if you have one), and overall health. The goal is to learn whether the newer ILAM method works better or just as well as the standard approach for treating VT.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

Date Added
January 13th, 2026
PRO Number
Pro00148932
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart
Summary

This research study is being done to evaluate a heart valve called the Navitor Transcatheter Aortic Valve, which may help treat people with severe aortic stenosis, a condition where the heart valve becomes too narrow to open properly. You are being asked to participate because your doctor believes you may benefit from a less-invasive valve replacement instead of open-heart surgery. The study will compare the Navitor valve to other FDA-approved transcatheter valves to see how safe and effective it is for people at low or intermediate surgical risk. The Navitor is considered investigational, meaning it is not yet approved in this population, by the Food and Drug Administration (FDA). Participation may last up to 10 years and involve up to 14 visits, some of which may be done remotely. If you join the study, you will have screening tests, the valve procedure, and regular follow-up visits for several years to check your heart health and how well the valve is working. The risks of participating are similar to those of standard transcatheter valve procedures, such as bleeding, stroke, heart rhythm changes, or infection. While you may experience symptom relief and improved heart function, personal benefit is not guaranteed. Your participation may also help improve future treatment options for patients with aortic stenosis.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Clinical Investigation Plan Title: Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)

Date Added
January 13th, 2026
PRO Number
Pro00148626
Researcher
Michele Esposito

List of Studies

Keywords
Cardiovascular, Heart, Non-interventional
Summary

This study is being done to see how well a device called FibroScan can detect high pressure in the large vein that carries blood to the heart. FibroScan is a quick, painless test that measures how stiff the liver is, and researchers want to know if those measurements can help identify people with elevated central venous pressure. You are being asked to participate because you have been suspected of having, or diagnosed with, heart failure. Everyone in the study will have the same tests, which include a FibroScan exam, heart ultrasound, EKG, blood work, and a right-heart catheterization. The study lasts about one week and includes a screening visit, a baseline visit, and a phone check-in. By taking part, you may help researchers learn whether this noninvasive device can provide useful information about heart function. Participation is completely voluntary, and choosing not to join will not affect your medical care.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu



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