Heart Transplant Review

Date Added
October 20th, 2023
PRO Number
Pro00129867
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Transplant
Summary

This study will include all adult (18 years or older) patients who received a heart transplantation at MUSC. This study will conduct a chart review of all adult heart transplant participants to understand how different variables including, donor and recipient comorbidities, donor and recipient medical history, donor and recipient social determinants of health, recipient length of time on transplant waitlist, donor cause of death (morbidity), donor conditions when harvested, recipient presence of mechanical circulatory support (MCS) (temporary or permanent), recipient reason for transplant, recipient use of inotropes and/or vasopressors, recipient pre-transplant lab values, recipient pre-transplant ECHO, recipient pre-transplant right heart catheterization (RHC), donor lab and test values, other donor and recipient imaging studies, recipient surgical time and patient stay data, donor-recipient prediction heart mass (PHM) ratio, recipient medications, donor medications, post-transplant follow-up data, as well as other donor and/or recipient variables, will affect heart transplant outcomes.

Institution
MUSC
Recruitment Contact
Brett Welch
3363174591
welcbret@musc.edu

A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke.

Date Added
October 10th, 2023
PRO Number
Pro00128979
Researcher
Michael Gold

List of Studies


Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study is comparing an investigational medication called asundexian (BAY 2433334) to the medication Eliquis for the prevention of stroke or blood clots in those with atrial fibrillation (AF). Atrial fibrillation is a condition in which the upper chambers of the heart beat irregularly, and AF increases the risk of stroke. Investigational means it is not yet approved for use by the US Food and Drug Administration (FDA). This is a randomized study which means participants are assigned by chance like the flip of a coin, to either asundexian or Eliquis. The medication will be taken by mouth daily. Participants will not know which medication they are assigned to. This study will last about 3 years and involve up to 13 clinic visits. Study related procedures include collecting medical history and medications, blood work, questionnaires, electrocardiogram (ECG) - a tracing of the heart's electrical activity, and collecting information about any side effects. Study medication related risks include bleeding, bruising, feeling sick, dry mouth, diarrhea and feeling dizzy.

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

Social Determinants of Health, Stress, Coping, and Quality of Life in Parents of Children with Congenital Heart Disease

Date Added
October 5th, 2023
PRO Number
Pro00131932
Researcher
Lianne Cole

List of Studies

Keywords
Cardiovascular, Children's Health, Heart, Mental Health, Pediatrics, Stress Disorders
Summary

This study will investigate the relationships among social determinants of health (SDOH), perceived stress, coping, and quality of life (QoL) in parents of children with congenital heart disease (CHD). Surveys will be administered to assess perceived stress, coping strategies, QoL, and SDOH. Semi-structured interviews with parents of children with CHD will explore parent experiences with CHD-related stressors, current use of coping strategies, SDOH barriers and facilitators to effective coping, and preferences for future interventions to reduce stress and facilitate coping.

Institution
MUSC
Recruitment Contact
Lianne Cole
336-207-8043
lianne.cole@childrens.harvard.edu

Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy

Date Added
August 14th, 2023
PRO Number
Pro00122591
Researcher
Stephanie Gaydos

List of Studies

Keywords
Heart
Summary

The study is being done to test the use of a drug called bromocriptine for women who have a condition called Peripartum cardiomyopathy or PPCM. PPCM means you have a weak heart after giving birth. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill. Bromocriptine is approved by the United States Food and Drug Administration (FDA) to treat irregular periods and other symptoms that result from having high blood levels of a substance called prolactin. It is not approved for use in usual care to treat PPCM. The follow up period will be about 3 years. The study will have an initial visit and then the follow -up visits will take place at one, three, six, and 12 months in the first year and visits by phone at 24 months and 36 months.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia

Date Added
August 8th, 2023
PRO Number
Pro00126883
Researcher
Marc-Andre Cornier

List of Studies

Keywords
Cardiovascular, Cholesterol, Coronary Artery Disease, Heart
Summary

This clinical research study is enrolling adults who have high triglycerides (fats in the blood). The study drug, olezarsen, is an investigational drug designed to reduce triglyceride blood levels. If you meet the requirements to participate in this study, you will be randomly assigned to receive either olezarsen or placebo (an inactive substance that contains no drug). During the treatment period, participants will be asked to complete visits every 4 weeks to include a total of 19 visits over approximately 16 months. If eligible, study medication and study visits will be provided free of charge. Compensation is available.

Institution
MUSC
Recruitment Contact
Kelcey Ladner
843-792-6043
ladnerk@musc.edu

Encore PFO Closure Device US IDE Randomized Trial - The PerFOrm Trial

Date Added
June 13th, 2023
PRO Number
Pro00128910
Researcher
Christopher Nielsen

List of Studies


Keywords
Heart
Summary

This study is enrolling adults between the ages of 18-60 who have a Patent Foramen Ovale (PFO). A PFO is a slit-like opening between the upper chambers (called atria) of the heart. This opening allows blood to flow between these chambers which can lead to a stroke. This study is examining an investigational device called the Encore PFO closure device. An investigational device is one that is not yet approved for commercial use by the US Food and Drug Administration (FDA) but is approved for use in this study. This study will last approximately 5 years and involve 9 visits. This is a randomized study meaning participants will be randomly assigned to receive the investigational PFO closure device or an FDA approved PFO closure device. Participants have a 50:50 chance to receive either device. Study related testing includes physical exams, blood test, echocardiogram (ultrasound test of the heart) electrocardiograms or ECG (test of the electrical activity of the heart) and the procedure to place the PFO closure device. There are risks involved with this study including access site related risks, bleeding and bruising, incomplete closure of the PFO with the closure device or other device related complications. There is potential benefit including reduced risk of a recurrent stroke.

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

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

Date Added
May 1st, 2023
PRO Number
Pro00127835
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Surgery
Summary

There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.

In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.

Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

Date Added
April 11th, 2023
PRO Number
Pro00126551
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Shortness of Breath
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.

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

Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu

Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for renal denervation in patients with uncontrolled stage 2 hypertension

Date Added
March 14th, 2023
PRO Number
Pro00126807
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

This study is seeking participants with uncontrolled high blood pressure despite taking blood pressure medications. The study is examining an investigational device, meaning not approved for commercial use or sale by the Food and Drug Administration (FDA), called the TIVUS System. TIVUS, or Therapeutic IntraVascular UltraSound (TIVUS™) System, is designed to denervate (deaden) the nerves surrounding the renal arteries (blood vessels going to the kidneys) as a way to help lower blood pressure. Participation in this study will last three years and involve approximately 11 in person visits and 3-4 telehealth visits. Study related procedures include blood pressure monitoring both in clinic and at home, 24 hour ambulatory blood pressure monitoring, questionnaires, blood work, electrocardiogram (ECG), which is a recording of the electrical activity of your heart, CT scan of your kidneys and blood vessels around your kidneys and the renal denervation procedure. Some of the risks include bruising, bleeding, pain or damage to the renal arteries.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu



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