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

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

BATwire - Percutaneous Implant Kit

Date Added
June 8th, 2021
PRO Number
Pro00107572
Researcher
Jean Ruddy

List of Studies


Keywords
Heart, Surgery
Summary

Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.

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

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

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

Assessment of myocardial Damage and Encephalopathy by Repeated Trauma (ALERT)

Date Added
May 18th, 2021
PRO Number
Pro00109049
Researcher
Federica del Monte

List of Studies


Keywords
Brain, Dementia, Genetics, Heart
Summary

Two groups of former athletes (who competed in contact and not-contact sports) will undergo brain and heart assessments. Additionally, blood and urines samples will be collected in order to investigate potential markers of disease.

Institution
MUSC
Recruitment Contact
Gianlorenzo Daniele
(843) 442-6981
daniele@musc.edu

The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea (LOFT-HF)

Date Added
March 25th, 2021
PRO Number
Pro00102395
Researcher
Chitra Lal

List of Studies


Keywords
Heart, Sleep Disorders
Summary

Central sleep apnea occurs when the brain fails to send a signal to the muscles that control breathing during sleep causing brief pauses in breathing. It is widely believed that treatment of central sleep apnea may improve heart failure and quality of life. The goal of this study is to evaluate the effectiveness of oxygen treatment in patients with both central sleep apnea and heart failure.

Institution
MUSC
Recruitment Contact
Andrew Stephens
8437923162
chamberam@musc.edu

Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study Protocol

Date Added
February 11th, 2021
PRO Number
Pro00105432
Researcher
Gary Headden

List of Studies


Keywords
Heart
Summary

The purpose of this study is to use an investigational device called the Atellica® VTLi™ test system to test a substance in your blood called troponin that may help with the diagnosis of a heart attack

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



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