SOPRANO: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation Save

Date Added
October 24th, 2017
PRO Number
Pro00069319
Researcher
Brian Houston

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to evaluate the effect of an investigational study drug called macitentan, on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the study drug in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. The study will compare macitentan with a placebo to see if taking macitentan is better than taking a placebo

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

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Save

Date Added
September 26th, 2017
PRO Number
Pro00069122
Researcher
John Sturdivant

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this research study is to evaluate the different ways to program a Cardiac Resynchronization Therapy Defibrillator (CRT-D) through the use of software built into the CRT-D system. A CRT-D does not cure heart failure, but many people who receive a CRT device notice that they feel better. The objective of the device programming required by the SMART CRT study is to provide heart failure therapy which improves heart function.

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

A multi-center randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction Save

Date Added
August 25th, 2017
PRO Number
Pro00065663
Researcher
Kurt Barringhaus

List of Studies

Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The purpose of this study is to test if LCZ696 taken twice a day, compared to ramipril taken twice a day, is safe and effective in reducing complications following an acute myocardial infarction (post-AMI), such as death from cardiovascular (CV) causes, hospitalization for heart failure (HF), or outpatient HF.

LCZ696 is a medicine which has been approved by the US Food and Drug Administration (FDA) for the treatment of people with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It has not been approved for treatment following a heart attack, the medical condition that you have. The medicine being tested in this study is not currently available for patients with your medical condition to receive a prescription for and/or to buy in any country. To date, over 21,000 subjects have taken LCZ696 in studies that have been performed in healthy subjects and patients with hypertension, heart failure with reduced ejection fraction, and heart failure with preserved ejection fraction.

The other medicine in this study, also called the comparator drug, is ramipril which is currently available on the market and approved for the treatment of patients with clinical signs of congestive heart failure post-AMI. Ramipril belongs to a class of medications called angiotensin-converting enzyme inhibitors, or ACE inhibitors (ACEIs), recommended as standard -of- care to treat the post-AMI patients.

Institution
Palmetto
Recruitment Contact
Kurt Barringhaus
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

Research Trial for Optimized Nonenhanced 3T QISS MR Angiography of the Peripheral Arteries Save

Date Added
August 17th, 2017
PRO Number
Pro00070277
Researcher
Uwe o.p. Schoepf

List of Studies


Profiles_link
Keywords
Cardiovascular, Vascular
Summary

The purpose of this study is to evaluate the use of a non-contrast MRI for the assessment of the vasculature of the lower extremity anatomical regions. Patients eligible for this study must have been referred for a clinical contrast enhanced CT scan or an invasive catheter angiography. The overall image quality and diagnostic accuracy of the non-contrast MRI will be compared to current clinical standards of care, such as contrast enhanced MRI, CT, and invasive angiography.

Institution
MUSC
Recruitment Contact
Brian Jacobs
843-876-4922
Jacobsbr@musc.edu

Hemodynamic Effects of Cardiac Resynchronization Therapy (CRT) on Subjects with Left Ventricular Assist Devices (LVADs) Save

Date Added
July 18th, 2017
PRO Number
Pro00067689
Researcher
Brian Houston

List of Studies

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Keywords
Cardiovascular, Heart
Summary

For some patients with heart failure, we know that using a special pacemaker configuration called cardiac resynchronization therapy (CRT) can help them feel better and live longer. In fact, in these patients, we can see improvements in cardiac function with CRT as early as a few beats after we turn it on. However, some patients continue to be sick after CRT and ultimately require more help. Some of these patients will get a surgically implanted pump (called a left ventricular assist device, or LVAD) that does the work of their heart. We do not know if CRT continues to help (or may hurt) these patients. In this study, we will assess the effects of CRT in LVAD patients in the short term.

Institution
MUSC
Recruitment Contact
Brian Houston
843-876-4787
houstobr@musc.edu

Heart Failure in Single Right Ventricle Physiology: Pathologic Mechanisms and Novel Assessment Save

Date Added
July 5th, 2017
PRO Number
Pro00066472
Researcher
Shahryar Chowdhury

List of Studies

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Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

The goals of this study are to understand the mechanisms behind the development of heart failure in children born with complicated heart defects consisting of a functional single pumping chamber, improve the ability to objectively measure cardiac function in these patients and determine the relationship of these pathophysiologic mechanisms to outcomes.

Institution
MUSC
Recruitment Contact
Christine Perez-Rosa
843-792-9454
perezaro@musc.edu

Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial fibrillation Save

Date Added
June 27th, 2017
PRO Number
Pro00067386
Researcher
Michael Gold

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this study is to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of SCAF (sub-clinical atrial fibrillation) detected by their pacemaker or ICD (intracardiac defibrillator) or ICM (insertable cardiac monitor) and also have other risk factors for stroke. Subjects will be randomly assigned to one of the two treatment strategies: apixaban or aspirin. Neither the subject nor the researcher will know which treatment the subject is assigned. Follow-up visits will occur every six months until the end of the study.

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction Save

Date Added
June 13th, 2017
PRO Number
Pro00065900
Researcher
Brian Houston

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to find out more about how an investigational study drug called omecamtiv mecarbil, works in people with heart failure. Omecamtiv mecarbil is also known as AMG 423. Omecamtiv mecarbil is an investigational medicine that increases the heart's ability to pump. In this study, omecamtiv mecarbil will be compared to placebo.

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

REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure Save

Date Added
May 9th, 2017
PRO Number
Pro00065245
Researcher
Sheldon Litwin

List of Studies

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. It will be a randomized, single blind (subject) trial. Subjects will be followed for two years and then annually for 3 years for a total of 5 years after implantation.

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

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay Pro Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Save

Date Added
April 21st, 2017
PRO Number
Pro00063368
Researcher
Daniel Clair

List of Studies

Keywords
Cardiovascular, Surgery, Vascular
Summary

This study is intended to include patients with a Thoracic Aortic Aneurysms (TAA) or Penetrating Atherosclerotic Ulcers (PAU) and assess and evaluate safety and performance data of the RelayPro Stent-Graft System. A TAA is a weakening and bulging of the thoracic aorta, which is the body's main blood vessel that carries blood away from your heart to all parts of your body. A disease called atherosclerosis, in which fatty material accumulates under the inner lining of the arterial wall, generally causes true aneurysms. PAUs are lesions associated with aortic wall thickening and appear similar to saccular aneurysms (sac-like bulging) on x-ray. If left untreated, an aneurysm or ulcer can enlarge and rupture, causing injury or death.

Institution
Palmetto
Recruitment Contact
Daniel Clair
(803)-545-5800
Daniel.Clair@uscmed.sc.edu

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