Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events- SCALE-HF 1

Date Added
November 18th, 2021
PRO Number
Pro00116583
Researcher
Priya Kumar

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study utilizes data from the Bodyport Scale to develop an index that allows for the early detection of worsening heart failure. Participants will receive training on how to use Bodyport Scale and will complete remote follow-up visits. Researchers will look at medical records for heart failure history and any clinical events related to heart failure.

Institution
Self Regional
Recruitment Contact
Erin Wallace
864-943-2416
erin.smith@selfregional.org

BIO-AffectDx Study

Date Added
October 26th, 2021
PRO Number
Pro00114778
Researcher
Anne Kroman

List of Studies

Keywords
Heart
Summary

This study is enrolling participants scheduled to have a cardiac resynchronization therapy defibrillator (CRT-D) implanted to treat their heart failure, a condition where the heart muscle is weakened and cannot pump blood effectively. Participants also need to have a history of atrial fibrillation (AF), a condition in which the top chambers of the heart beat irregularly. A CRT-D device works by placing wires called leads in the heart that receive electrical signals programmed to coordinate or synchronize the heartbeat to help pump blood more effectively. The purpose of this study is to collect follow up data for a year post implant. Study procedures include completing questionnaires, six minute walk test and physical assessments. Participation in this study will include 4-5 visits over the course of about one year.

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

An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Date Added
October 12th, 2021
PRO Number
Pro00114829
Researcher
Daniel Judge

List of Studies


Keywords
Drug Studies, Heart
Summary

Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study will continue to evaluate the safety and tolerability of a new drug called acoramidis given to adult patients with symptomatic transthyretin amyloid cardiomyopathy. All participants will be given the study medication, which is taken by mouth twice a day.

This study is enrolling subjects who participated in the AG10 301 study, and are eligible to enroll in this study within 30 days of completing the 30 month visit for the AG10 301 study. This study is expected to last approximately 5 years and will have in person visits at day 1, month 1 and then every 6 months along with phone visits quarterly when an in person visit is not required.

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

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The RAPID Study (NODE-301 Part 2)

Date Added
September 28th, 2021
PRO Number
Pro00113657
Researcher
John Wharton

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is seeking participants with Paroxysmal Supraventricular Tachycardia (PSVT) which is a specific type of fast heart rhythm, to participate in a randomized study using an investigational (not yet approved for commercial use or sale by the US Food and Drug Administration (FDA) medication versus placebo (looks like medication but there is no active ingredient). The study medication, known as Etripamil, is a nasal spray. Participants will receive a test dose of the medication to see its effect, then be taught to give themselves the medication so the treatment can be done in a home setting. Participants will then be randomized (assigned by chance) to study medication vs placebo to use at home when an episode of PSVT occurs. Participants will also be shown how to place a heart monitor on their chests to record while using the study medication. Participation in this study will last approximately 12-18 months and will include at least 4 clinic visits including screening/test dose visit, randomization treatment, randomization treatment follow up and final study visit. In addition to these 4 visits you will also have a monthly study call or clinic visit to check in with you. Physical exams, vital signs, blood work, urinalysis, ECGs (recording of electrical activity of the heart), placing and using a heart monitor and communicating with a telephone coach are all part of the study procedures.

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

Date Added
September 14th, 2021
PRO Number
Pro00111178
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Obesity
Summary

The purpose of this research study is to evaluate the safety and effectiveness of tirzepatide compared to placebo (an inactive substance) in the treatment of individuals with Heart Failure with Preserved Ejection Fraction (HFpEF) and obesity.

Participants will undergo a screening visit where they will have a physical exam to asses health and blood will be drawn. If the blood tests show that a participant qualifies to continue, then they will be randomly assigned to either tirzepatide or placebo. Each participant will have a 50:50 chance of being on tirzepatide (like the flip of a coin.) Both tirzepatide and placebo will be supplied as a single dose in an injectable pen device. Subjects will inject the study drug under the skin (or subcutaneous) once a week with the injectable pen. Participation will last at least 52 weeks and may last up to 120 weeks.

Tirzepatide has been proven to provide significant body weight loss and improvement of fat and sugar metabolism in patients with type 2 diabetes. Body weight percent reduction in this study is estimated to be 15% to 16%.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-792-5873
johnjacq@musc.edu

MINDS Imaging Ancillary Study

Date Added
September 1st, 2021
PRO Number
Pro00111435
Researcher
John Rhodes

List of Studies


Keywords
Heart
Summary

Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
headleyt@musc.edu

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Date Added
August 24th, 2021
PRO Number
Pro00112813
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

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

Clinical Evaluation of the i-STAT hs-TnI Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Date Added
August 3rd, 2021
PRO Number
Pro00110711
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared with Standard of Care Ablation in Patients with Paroxysmal Atrial Fibrillation

Date Added
July 27th, 2021
PRO Number
Pro00109204
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study will examine a new ablation catheter for the treatment of drug resistant paroxysmal atrial fibrillation. Atrial fibrillation is an irregular heart beat that causes the upper chambers of the heart to beat out of sync. Paroxysmal means this irregular heart beat starts and stops on its own. When medications used to keep your heart in rhythm no longer work or cause unwanted side effects an ablation procedure is recommended. For this study the FARAPULSE™ Pulsed Field Ablation System including the FARAWAVE™ Pulsed Field Ablation Catheter will be used. This system including the catheter are investigational meaning it has not been approved for use by the US Food and Drug Administration. (FDA) Participation in this study will last about a year and will include up to five in person visits and four remote/telephone visits.

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

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ON THE SAFETY AND EFFICACY OF ISTAROXIME FOR PRE-CARDIOGENIC SHOCK (SEISMiC)

Date Added
June 22nd, 2021
PRO Number
Pro00107597
Researcher
Adrian Van Bakel

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is for patients who are currently hospitalized with heart failure, a condition where the heart muscle is weakened and cannot pump blood effectively, and have low blood pressure. This study involves an investigational, not yet approved by the US Food and Drug Administration (FDA) intravenous (given into a vein) medication that is being studied to see if it can help increase blood pressure. The study involves a screening visit, randomization which is where either the study medication or placebo is assigned randomly, medication or placebo infusion for 24 hours, visits at day 2,3 and 4 and then a final visit at day 30.

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



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