Right Ventricular Reserve Measures with Cardiac MRI Save

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
8437921869
aanstoos@musc.edu

Pulmonary Hemodynamics during Exercise - Research Network Save

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial Save

Date Added
March 26th, 2019
PRO Number
Pro00087159
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Heart, Pediatrics
Summary

This study is for patients that are survivors of childhood cancer who received a type of treatment called anthracycline chemotherapy at a young age. The investigational drug in this study is carvedilol. Medications such as carvedilol have been shown to improve heart function and delay the onset of heart failure. However, carvedilol has not been studied in a large group of childhood cancer survivors who received anthracycline chemotherapy. The purpose of this study is to see if a two-year course of carvedilol in childhood cancer survivors to see if it will have the same effects as shown in these prior studies of people with mild heart failure or who were at risk for heart failure. People in this clinical trial are expected to receive treatment on this study for about 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial) Save

Date Added
March 4th, 2019
PRO Number
Pro00086011
Researcher
Daniel Judge

List of Studies

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Keywords
Cardiovascular, Genetics, 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 is evaluating the safety and tolerability of a new drug called AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy. The participant will be randomized to the study drug or placebo and take the study drug two times per day for 30 months.

Institution
MUSC
Recruitment Contact
Anita Smalls
(843) 876-5011
smaani@musc.edu

Safety and Effectiveness of TactiCath Contact Force, Sensor Enabled (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation Save

Date Added
February 12th, 2019
PRO Number
Pro00083338
Researcher
Jeffrey Winterfield

List of Studies

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Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating your symptomatic, persistent atrial fibrillation that is not effectively treated with medication. Participation in the study will last about 15 months from the time of the ablation procedure. Participant will be asked to complete follow-up visits at 7-days (phone call visit only), 3-months, 6-months (phone call), 12-months (phone call or in-person), and 15-months 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
Deborah Everidge
843-792-2944
adamsde@musc.edu

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure Save

Date Added
November 13th, 2018
PRO Number
Pro00083036
Researcher
Sheldon Litwin

List of Studies

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Keywords
Diabetes, Heart, Hypertension/ High Blood Pressure
Summary

Volunteers are being asked to participate in a clinical research study to find out if the drug dapagliflozin is safe and effective compared to placebo (an inactive substance) in the treatment of people with heart failure with preserved ejection fraction (ability of the heart to relax and squeeze to pump out blood). AstraZeneca is doing this research to find out if the new medication called dapagliflozin will work and be safe for the treatment of heart failure in addition to standard therapy used for treatment of heart failure. The study is planned to go on for about 33 months and include 4700 patients from about 21 countries.

This research study is carried out to see if dapagliflozin is effective in preventing worsening of heart failure and improving survival in patients with heart failure and preserved systolic function. The placebo tablet will look identical with the dapagliflozin tablet. During the study participants will either receive dapagliflozin 10 mg once a day or an identical-looking placebo once a day. Which study drug subjects will receive throughout the study is decided at random by a computer (purely by chance, like the tossing of a coin). Subjects have a 50% chance of receiving dapagliflozin and a 50% chance of receiving placebo. Subjects and the study doctor will not know which study drug the participants receive.

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

in Situ measurement of anti-apoptotic Phenotype in the pulmonary arterIal endothelium and its association with pRe-capillary disEase in Pulmonary Hypertension Save

Date Added
October 16th, 2018
PRO Number
Pro00081988
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Heart, Pulmonary Arterial Hypertension (PAH)
Summary

This study will involve subjects undergoing clinically indicated Right heart catheterization for either idiopathic pulmonary arterial hypertension (IPAH) or heart failure with preserved ejection fraction (HFpEF). The catheter tip utilized in the procedure, which would otherwise be discarded, will be collected and tested. A test performed on the cells adhered to the end of the catheters has been developed which we believe can aid in the differentiation of patients diagnosed with IPAH vs. HFpEF.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF QPI-1002 FOR THE PREVENTION OF MAJOR ADVERSE KIDNEY EVENTS (MAKE) IN SUBJECTS AT HIGH RISK FOR ACUTE KIDNEY INJURY (AKI) FOLLOWING CARDIAC SURGERY Save

Date Added
September 4th, 2018
PRO Number
Pro00080148
Researcher
Marc Katz

List of Studies

Silhouette
Keywords
Drug Studies, Heart, Kidney, Surgery
Summary

The purpose of this study is to test whether the study drug (QPI-1002) prevents Major Adverse Kidney Events (MAKE) after heart surgery in adult patients who are at high risk of developing Acute Kidney Injuries (AKI). This study is a one-time infusion of the study drug (QPI-1002) with follow-up visits lasting for one year.

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

Human Samples Biorepository Save

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica Del monte

List of Studies

Silhouette
Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

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