CardioMEMS HF System Post Approval Study Save

Date Added
July 17th, 2017
PRO Number
Pro00062661
Researcher
Daniel Steinberg
Keywords
Cardiovascular, Heart
Summary

This is a prospective, multi-center, open-label trial conducted in the United States (US). The study is designed to collect real world data on subjects with heart failure who are receiving the CardioMEMS HF System. The CardioMEMS is an approved medical device. The CardioMEMS device is designed to provide current measurements of a specific heart pressure to physicians. This information will help guide medical therapy in order to help prevent heart failure hospitalizations.

Institution
MUSC
Recruitment Contact
Laura Waters
843-876-8921
waters@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
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
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
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
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 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function Save

Date Added
March 28th, 2017
PRO Number
Pro00063152
Researcher
Adrian Van Bakel
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety, and effectiveness of BMS-986231 (HNO DONOR) in patients with acute heart failure when added to the standard treatment. Reduced strength of contraction can mean that your heart is not pumping most of the blood out of your heart with each beat. The study drug will be given as a continuous 48-hour infusion (through an IV) during the hospital stay. There will be a follow up visit at 30 days. All adults who meet inclusion criteria will be approached for this study.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT Save

Date Added
February 28th, 2017
PRO Number
Pro00062003
Researcher
James Thomas
Keywords
Cardiovascular, Cholesterol
Summary

Research study looking for participants with, or at high risk for, cardiovascular disease (CVD). This study is being carried out to see if a new investigational drug called bempedoic acid provides cardiovascular benefits and decreases the risks of future cardiac events when taken by patients who are not able to take a type of medication called statins. The study may require up to 15 visits to the clinic over a period of five years.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-876-5012
macnichd@musc.edu

Lymphangiogenesis Factors in Heart Failure States (LYFT-HF study) Save

Date Added
February 21st, 2017
PRO Number
Pro00062457
Researcher
Brian Houston
Keywords
Cardiovascular, Heart
Summary

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. We think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. We do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to see if we can figure out how the lymph vessels of people with long-standing heart failure might grow.

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

CAscade SCreening for Awareness and DEtection of Familial Hypercholesterolemia Save

Date Added
January 2nd, 2017
PRO Number
Pro00059316
Researcher
Pamela Morris
Keywords
Cardiovascular, Cholesterol
Summary

The CASCADE FH Registry is a national, multi?center initiative that will track the therapy, clinical outcomes, and patient?reported outcomes over time. The Registry represents collaboration between The FH Foundation, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes. The Duke Clinical Research Institute will help operationalize the clinical portal of the CASCADE FH Registry. The Registry will use a hybrid enrollment design to maximize outreach and ensure that all interested FH patients have the option to participate. In accordance with these goals, participants will be identified using a variety of mechanisms, including screening by providers and online screening tools available to the general public. MUSC will only follow the clinical, prospective data collection method outlined in the protocol for this study. Cross?validation of clinical data with patient?entered data will optimize quality and promote statistical validity.

Institution
MUSC
Recruitment Contact
Ariane Shokri
843792-1274
shokria@musc.edu

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention Save

Date Added
December 13th, 2016
PRO Number
Pro00058654
Researcher
Andrew Atz
Keywords
Cardiovascular, Drug Studies, Pediatrics
Summary

This is a prospective, randomized, open-label, Phase II, multi-center clinical trial for pediatric subjects with congenital or acquired heart disease who are on blood thinners. Subjects will be assigned by chance (2:1) to apixaban,vitamin K antagonist or low molecular weight heparin.

Recruitment will start first for subjects 2 years old to less than 18 years old. Recruitment for subjects from 0 to less than 2 years of age will be delayed until study data from the 2 to less than 18 years of age is analyzed.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

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