A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Date Added
June 8th, 2021
PRO Number
Pro00110317
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of ION-682884 and determine if it can help people with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). ION-682884 is an investigational drug. "Investigational" means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. 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. However, it is not known if ION-682884 will help your cardiomyopathy.

If you meet the requirements and agree to participate in this study, you will receive subcutaneous (under the skin) injections of either ION-682884 or placebo once every 4 weeks from week 1 through week 117.
Your participation in this study will last approximately 36 months and will consist of clinic visits and follow up visits at home.

Institution
MUSC
Recruitment Contact
Hannia Ramos
843-876-4806
ramosha@musc.edu

Behavioral Activation Delivered via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged from Inpatient Care

Date Added
June 1st, 2021
PRO Number
Pro00110159
Researcher
Ronald Acierno

List of Studies

Keywords
Cardiovascular, Depression, Mental Health, Military
Summary

Patients with cardiovascular disease (CVD) are at increased risk of depression following hospital discharge. Unfortunately, most depressed CVD patients do not receive appropriate care for their depression, often because they are unable to, or are fearful of traveling to providers for the regimen of 8-12 weekly visits of therapy such as Behavioral Activation (BA). This study will compare the effectiveness of BA for depression, delivered via Telehealth, to standard post-CVD hospital discharge best practices. It is predicted that patients who receive BA will have better mental health outcomes and will be less likely to be re-hospitalized compared to patients who receive standard post-discharge care.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Implantation of the HeartMate 3 in Subjects with Heart Failure using Surgical Techniques Other Than Full Median Sternotomy

Date Added
May 25th, 2021
PRO Number
Pro00107646
Researcher
Lucas Witer

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is looking for volunteers who are having the Heart Mate 3 (HM3) Left Ventricular Assist Device (LVAD) implanted for treatment of heart failure. The study will collect medical information and patient experiences who have received treatment with the HM3. The traditional method to implant the HM3 is an incision in the middle of the chest through the breastbone (also called the sternum). This study will collect data if you have the Heartmate 3 implanted using a less invasive approach. Study participants will attend 8 visits over the course of 6 months.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Gayenell Magwood

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@musc.edu

A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Date Added
April 21st, 2021
PRO Number
Pro00106141
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Diabetes, Heart, Kidney, Surgery
Summary

The goal of this study is to find out if an investigational drug called ASP1128 (also called as MA-0217) is effective and safe as a treatment to prevent acute kidney injury (AKI) and/or reduce its severity in people who are at risk for AKI after heart surgery when compared to placebo (inactive substance). Researchers will look at how ASP1128 can act in the body.

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

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction: Randomized Controlled Feasibility Trial- The REBALANCE-HF Study

Date Added
February 9th, 2021
PRO Number
Pro00107509
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular
Summary

This study will include volunteers diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called "heart failure with preserved ejection fraction" or HFpEF. For these individuals, it has been determined that the health problems and symptoms experienced may be due to a significant increase in the pressure of one of the chambers of the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk.

This study is to help evaluate a new device (the "Axon System") designed to reduce the build-up of pressure described above. The Axon system is a catheter used to ablate or destroy the splanchnic nerve on one side of the body. The Sponsor believes by destroying this nerve there may be some reduction in the symptoms caused by HFpEF. The procedure using the Axon System will be performed in the catheterization lab and does not involve surgery. Participants will stay overnight in the hospital following the procedure for observation.

The length of subject participation in the study will be approximately 12 -14 months and includes 7 office visits, 2 phone calls and 3 procedures. Participants in this research study will be randomized to either the treatment group or the control group and have a 50:50 chance of receiving the research treatment with the Axon System at the time of randomization.

This study will help us learn more about how safe and effective the Axon System is in treating the symptoms of patients with HFpEF.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

VIVO Protocol: Feasibility of Merging VIVO with inHEART

Date Added
December 23rd, 2020
PRO Number
Pro00094238
Researcher
Michael Gold

List of Studies


Keywords
Cardiovascular
Summary

The purpose of the study is to give more information about how the VIVO software and inHEART software merge together and what potential benefits this could provide the physician for planning ablation procedures. In addition, the study will also provide information about the accuracy of VIVO in varying degrees of damaged hearts.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2244
adamsde@musc.edu

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth): A Randomized Clinical Trial

Date Added
December 7th, 2020
PRO Number
Pro00084526
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Children's Health, Heart
Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Institution
MUSC
Recruitment Contact
Mary Freeman
8437925762
freemanme@musc.edu

Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation (TactiFlex PAF IDE Trial)

Date Added
October 13th, 2020
PRO Number
Pro00101068
Researcher
Michael Field

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating (burning heart tissue using heat energy) your symptomatic, paroxysmal (starts and stops on its own) atrial fibrillation (irregular heart beat in upper chambers of heart) that is not effectively treated with medication. Participation in the study will last about 12 months from the time of the ablation procedure. Participants will be asked to complete follow-up visits at 7-days (phone call visit), 5 weeks (phone call visit) 3-months (in person visit), 6-months (in person visit), and 12-months (in-person visit). Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

Multicenter Study Into Individualized Scanning for Coronary Artery Disease (MINDS-CAD)

Date Added
July 14th, 2020
PRO Number
Pro00100282
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease
Summary

This study uses CT scans to visualize the heart and surrounding arteries to look for coronary artery disease. This study takes into account individuals body type including size, weight, and heart rate to tailor the CT scan and contrast media given to each patient. Taking into account each patients body will allow doctors to obtain the best image possible while reducing the amount of contrast media given to patients.

Institution
MUSC
Recruitment Contact
Hunter Gray
8438764922
grayhu@musc.edu



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