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

List of Studies

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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

List of Studies


Profiles_link
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

List of Studies

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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

List of Studies


Profiles_link
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

AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial Save

Date Added
November 22nd, 2016
PRO Number
Pro00060406
Researcher
John Sturdivant

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart
Summary

The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the Amulet device is safe and effective when compared to another LAA closure device made by another medical device company named Boston Scientific. The other device, called the WATCHMAN LAA closure device, is approved for use in the United States and many countries in Europe, Australia, and other nations. It is implanted in some patients with non-valvular atrial fibrillation to reduce the risk of stroke. The WATCHMAN device will be used as the Control device in this study.

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

BIOTRONIK, Inc. Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads Save

Date Added
October 25th, 2016
PRO Number
Pro00056102
Researcher
Sultan Siddique

List of Studies

Keywords
Cardiovascular, Heart, Surgery
Summary

The BIOTRONIK QP ExCELs study is a prospective, non-randomized, multi-center clinical investigation is to evaluate the safety and effectiveness of the BIOTRONIK Sentus over-the-wire (OTW) QP left ventricular (LV) lead. Male and female patients 18 years of age or older who have standard Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication may be eligible to participate in this study. This clinical protocol includes a single-arm, multi-center, prospective MultiPole Pacing (MPP) sub-study to demonstrate the MPP feature is effective by converting a percentage of CRT non-responders to responders.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Sultan Siddique, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Sultan Siddique
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) Save

Date Added
October 18th, 2016
PRO Number
Pro00059616
Researcher
Bhavadharini Ramu

List of Studies

Silhouette
Keywords
Cardiovascular, Heart, Vaccine
Summary

INVESTED is a multi-site trial comparing high-dose (60 ?g per vaccine viral strain) trivalent influenza vaccine to standard-dose (15 ?g per viral strain) quadrivalent influenza vaccination for up to three influenza seasons in high-risk cardiovascular disease patients with a history of myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months. Subjects will be randomly assigned to receive either the high-dose or standard-dose vaccine.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

Actelion Protocol AC-055-205: 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
August 5th, 2016
PRO Number
Pro00053983
Researcher
Patrick Mccann

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Pulmonary Arterial Hypertension (PAH), Vascular
Summary

The Actelion SOPRANO study is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase II study to evaluate the safety and effect of macitentan on pulmonary vascular resistance in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation. Male and female patients 18 years of age or older who have had surgical implantation of LVAD may be eligible to participate in this study.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Patrick McCann, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Patrick McCann
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease Save

Date Added
June 23rd, 2016
PRO Number
Pro00056522
Researcher
Frances Woodard

List of Studies

Keywords
Cardiovascular, Children's Health, Heart, Infant, Non-interventional
Summary

Transforming health care and outcomes for children with rare diseases is difficult within the current health care system. There is great variation in care delivery, inadequate and slow application of existing evidence, and ineffective use of available data to generate new knowledge. Individual care centers have inadequate numbers of patients for robust learning and improvement. In order to redesign the system, changes must take place at multiple levels, including the patient and family, clinician, practice and the network. The purpose of this project is to design, develop, and test further refinements to an improvement and research network focused on HLHS, the most severe congenital heart defect, and to use a registry to simultaneously improve clinical care, redesign care delivery systems and to conduct quality improvement, health services, outcomes, and comparative effectiveness research. The purpose of this initiative, specifically, is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes. We utilize a quality improvement methodology, known as the adapted learning collaborative model, which expedites the implementation of tools and strategies that facilitate changes such as systematic care coordination, cardiovascular monitoring, and nutritional monitoring into every day practice. The NPC-QIC registry is used to document the impact of these changes on various care processes and outcomes (e.g., mortality rate, readmissions, and weight gain).

Institution
MUSC
Recruitment Contact
Frances Woodard
843-792-3292
klinefl@musc.edu

The RADIANCE-HTN Study: A Study of the ReCor Medical PARADISE System in Clinical Hypertension Save

Date Added
January 12th, 2016
PRO Number
Pro00051260
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a clinical study looking at the effectiveness and safety of a new device called The Paradise System to use for renal denervation in patients who have mild to resistant hypertension. The goal of renal denervation is to lower blood pressure by using ultrasound waves to heat and disable the nerves surrounding the blood vessels leading to the kidneys. It is believed these nerves may be too active in patients with high blood pressure. The study is divided into two groups, those on one to two anti hypertensive medications (Solo) and those on three or more(Trio). The Trio group will stop their current medication regime and be given one of two combination medications while monitoring their blood pressure. If they continue to meet inclusion criteria, they will be randomized to undergo a renal denervation procedure using the new system versus no procedure. Their assignment will not be made known to them until their six month follow up visit. All groups will be followed up to 3 years but patients who did not initially have the procedure will have the opportunity to have it at a later date.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
843-876-5783
paladugc@musc.edu

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