A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date Added
September 12th, 2023
PRO Number
Pro00131432
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for patients with obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body.

The study is done to compare the side effects and effectiveness of an investigational (not yet approved by the Food and Drug Administration (FDA)) medication with the beta-blocker metoprolol succinate in participants with oHCM. The study medication is known as Aficamten and is a tablet taken by mouth. This is a randomized study (participants will be assigned by chance to the study medication Aficamten and placebo or metoprolol succinate and placebo). A placebo looks just like the study medication but has no active ingredient in it. The medications will be administered in the form of a pill. This study will take about 9 months and include about 11 visits to the study site. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), exercise testing, physical exams, questionnaires and optional genetic testing. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

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

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.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

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

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 Health Columbia Medical Center
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

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu



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