A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

Date Added
December 9th, 2025
PRO Number
Pro00147257
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
Washoliv@musc.edu

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

Date Added
December 9th, 2025
PRO Number
Pro00148422
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.

This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.

Institution
MUSC
Recruitment Contact
Natalie Forrester
843-876-5037
drain@musc.edu

Right Ventricular Function, Hepatic Metabolic Function, and Relationship to RV-PA Coupling in Patients with Tricuspid Regurgitation

Date Added
November 18th, 2025
PRO Number
Pro00148059
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart
Summary

This study is enrolling two different groups of individuals. The first group are those individuals referred for right heart catheterization (RHC), which is a procedure performed to check heart pressure taken inside the heart. The second group of individuals are those who have tricuspid regurgitation (TR) (blood that leaks due to improper valve closure) and are undergoing tricuspid valve intervention to correct the regurgitation. The RHC group will be referred to as the control group and the tricuspid intervention group will be the treatment group in this study. This study involves collecting existing medical records on both groups, as well as an arterial (from an artery) blood sample and venous (from a vein) blood sample from the vein that carries blood away from the liver. The control group will not involve any additional procedures or follow up. The TR population will perform a 6 minute hall walk test before their tricuspid valve intervention and again during the six month post procedure follow up. The TR group will also have repeat arterial and venous blood collection at the six month follow up. The TR group will have data collected for up to two years post tricuspid valve intervention.

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

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Date Added
November 18th, 2025
PRO Number
Pro00147339
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is testing a new treatment for people with a dangerous heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, leading to fainting, heart failure, or even sudden death. Some people continue to have VT even after taking medicines and undergoing standard ablation procedures. For these patients, current treatment options are very limited.

The investigational treatment uses the Thermedical Ablation System with the Durablate™ catheter. This device delivers both heat and saline (salt water) deep into the heart muscle to target the areas causing abnormal rhythms. The goal is to safely and effectively reduce or eliminate VT episodes in patients who have not responded to other therapies.

About 130 patients will be enrolled at up to 25 hospitals in the U.S. and Canada. Participants will have the procedure and then be followed for six months with regular checkups to see if the treatment reduces their VT episodes and improves their quality of life. This study will help determine if the new system should be approved for wider clinical use.

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

The Single Ventricle Outcomes Network (SV-ONE)

Date Added
November 14th, 2025
PRO Number
Pro00147843
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Heart, Infant
Summary

SV-ONE represents the integration of NPC-QIC within the existing FON framework. As such, SV-ONE will engage in research and improvement efforts through the entire lifespan of patients with SVHD, including but not limited to those with a Fontan circulation. The larger objective of this study is to increase longevity and enhance the QoL by improving physical health and functioning, mental health and resilience, and neurodevelopment for individuals with SVHD and their families. A longer-term goal of SV-ONE will be to serve as a platform for research and improvement that will
accelerate advances, with the potential to nest clinical trials and to link to registries and programs,
nationally and internationally.

Institution
MUSC
Recruitment Contact
Frances Woodard
843-792-3292
klinefl@musc.edu

A Phase 1/2 Long-term Follow-up Study of the Safety and Efficacy of LX2020 Gene Therapy in Patients with Arrhythmogenic Cardiomyopathy due to a Plakophilin-2 Pathogenic Variant (GRIT-PKP2)

Date Added
November 12th, 2025
PRO Number
Pro00147805
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The GRIT-PKP2 study will evaluate the long-term safety and tolerability of LX2020 gene therapy for subjects with PKP2-ACM who have previously received an investigational study medication called LX2020. PKP2-ACM is an inherited heart condition which can cause heart muscle and electrical damage. Investigational means it is not approved for use by the Food and Drug Administration (FDA). There is no investigational treatment being administered in this study. The overall study duration is 4 years. The study consists of 7 visits: a rollover visit, an outpatient monitoring period, (5 visits, 18 months to 48 months after LX2020 administration in Study LX2020-01), and an end-of-study visit. Procedures and activities that subjects will undergo are: quality of life questionnaires, ECG, MRI, ultrasound, ECHO, collection of samples, remote cardiac monitoring, and collection of vital signs.

Institution
MUSC
Recruitment Contact
Tania Pegues
843-876-6996
peguest@musc.edu

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III Heart Failure Patients

Date Added
November 12th, 2025
PRO Number
Pro00147296
Researcher
Vishal Rao

List of Studies

Keywords
Heart, Pulmonary Hypertension
Summary

This study is enrolling patients diagnosed with New York Heart Association (NYHA) Class II and III Heart Failure (HF). The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure Hospitalizations (HFH). The study is divided into 3 time periods: a screening period, implant/treatment period, and a follow-up period.

The study involves implanting a Cordella™ Pulmonary Artery Sensor during a right-heart catheterization, after which, you will be randomized into the treatment group (your study doctor will use the data from your daily weight, blood pressure, heart rate measurements, and your daily sensor readings to treat your heart failure) or the active control group (your study doctor will only use the data from your daily weight, blood pressure, and heart rate measurements to treat your heart failure). You will have a 66% (2 in 3) chance of being in the treatment group and a 33% (1 in 3) chance of being in the active control group. Randomization is much like a like drawing straws where you have a 66/33 chance of being assigned to the treatment group or the active control group.

After you have been implanted for 6 months, you and your study doctor will be "unblinded" (able to see) the daily measurements from the Cordella™ Pulmonary Artery Sensor System. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months, then annually up to 5 years.

Risks include complications from the implant procedure (bleeding, infection, damage to blood vessels, allergic reactions), risks from contrast dye, anesthesia, or medications (e.g., bleeding from blood thinners), and potential unknown device-related risks.

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

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)

Date Added
October 14th, 2025
PRO Number
Pro00146373
Researcher
Daniel Judge

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with symptomatic ATTR-CM (transthyretin amyloidosis cardiomyopathy). ATTR-CM is a rare and serious disease that occurs when a protein in the blood called transthyretin (TTR) builds up throughout the body, including in the heart and nerves. When the abnormal protein, known as amyloid, deposits in the heart, the heart muscle thickens and stiffens, causing the heart to fail. This research study is designed to test whether the medication nucresiran is safe and helps people with ATTR-CM, in comparison to the effects of placebo.

Nucresiran is considered investigational, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of ATTR-CM. Nucresiran is a TTR silencer. It is like a "quiet button" that turns down the amount of the disease-causing protein that is made. Because there is less TTR, there may be less buildup in the heart and other organs over time.

This is a randomized study meaning once eligibility is confirmed, participants will be assigned by chance, like drawing straws, to either receive nucresiran or placebo. You will have a 2 out of 3 chance of being assigned to nucresiran and a 1 out of 3 chance of being assigned placebo. Placebo is a substance that looks like the actual medication and is given the same way but contains no active substance. The study drug, which can be either nucresiran or placebo, will be given as an injection under the skin in the abdomen (avoiding the area around the navel), thigh, or the side or back of the upper arms. Neither the participants nor the study doctor will know who is assigned to nucresiran or placebo but this information can be made available if need be.

Participation in this study is expected to last for 5-8 years, Study related procedures include physical exams, vital signs, echocardiograms (ultrasound test of the heart), electrocardiograms, (ECG, a tracing of the heart's electrical activity), blood work, urine samples and questionnaires. Participants will also take Vitamin A daily. Study related risks include risks related to the study drug including injection site reactions, abnormal liver function or an allergic reaction. There may be risks related to study procedures including loss of confidentiality. There may not be any direct benefit, but the information learned may benefit others with ATTR-CM in the future.

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

WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Alternative Post-Implant Monotherapy

Date Added
September 10th, 2025
PRO Number
Pro00141485
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

This study will have a 1:1:1 randomization post the implantation of the WATCHMAN DLX Pro Device comparing three different medications used after the WATCHMAN FLX Pro Device is placed. The goal of this study is to see how safe and effective the medications are after the device is placed. The three different arms include the following: Aspirin only for 12-month study duration, reduce dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC), either commercially available apixaban (preferred) or rivaroxaban for first 3-months, followed by aspirin, or Aspirin +clopidogrel) for first 6 months followed by aspirin only.

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

Study of the Prevalence of Endogenous Hypercortisolism in Patients with Resistant Hypertension (MOMENTUM)

Date Added
August 12th, 2025
PRO Number
Pro00145257
Researcher
Jan Basile

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is looking for individuals who have resistant hypertension. This is a non-interventional research study and it does not involve a new drug or treatment. The goal of this study is to find out how many people with resistant hypertension, a type of high blood pressure that is hard to control, also have high levels of a hormone called cortisol. High cortisol levels, a condition called hypercortisolism, may make it more difficult to manage blood pressure. If you join the study, you will attend two to three clinic visits. During the first visit, you will go to the clinic for a short checkup. You will have vitals and your medical history reviewed. You will also have a blood draw and be given a pill called dexamethasone which will help us assess your cortisol levels. At your second visit you will fast and have a your blood collected to review your cortisol levels. If necessary, you will be invited for a third visit where you will get a CT scan. The risks associated with the study include bruising, dizziness, or, in rare cases, infection from blood draws, allergic reactions from taking the dexamethasone pill, and exposure to radiation from the CT scan. The study will be completed over the course of 2-3 visits in one months timeframe.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-876-5785
washoliv@musc.edu



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