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


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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

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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 phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF) Save

Date Added
September 26th, 2018
PRO Number
Pro00078618
Researcher
Ryan Macnevin

List of Studies

Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

This study will investigate the superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction and meet the following criteria:

Inclusion criteria
1. Age ? 18 years at screening. For Japan only: Age ? 20 years at screening
2. Male or female patients. WOCBPa must be ready and able to use highly effective methods of birth control per ICH M3 (R2) [R09-1400] that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information
3. Patients with chronic HF diagnosed for at least 3 months before Visit 1, and currently in HF NYHA class II-IV
4. Chronic HF with reduced EF defined as LVEF ? 40% per local reading (obtained under stable condition by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT). A historical LVEF may be used if it was measured within 6 months prior to visit 1 or the LVEF may be measured after study consent has been obtained. The LVEF must be documented in an official report prior to randomization.
5. In addition to LVEF ? 40%, patients must have at least one of the following evidence
of HF:
a) If EF ?36% to ?40%: Elevated NT-proBNP at Visit 1 ?2500 pg/ml for
patients without AF, OR ?5000 pg/ml for patients with AF, analysed at the
Central Laboratory,
b) If EF ?31% to ?35%: Elevated NT-proBNP at Visit 1 ?1000 pg/ml for
patients without AF, OR ?2000 pg/ml for patients with AF, analysed at the
Central Laboratory,
c) If EF?30%: Elevated NT-proBNP at Visit 1 ?600 pg/ml for patients without
AF, OR ?1200 pg/ml for patients with AF, analysed at the Central Laboratory
d) For EF ? 40% and documented HHFc within 12 months prior to visit 1,
elevated NT-proBNP at Visit 1 ? 600 pg/ml for patients without AF and ?
1200 pg/ml for patients with AF, analysed at the Central Laboratory.
6. Appropriate dose of medical therapy for HF (such as ACEi, ARB, ?-blocker, oral
diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international
CV guidelines, stable for at least 1 week prior to Visit 1 and during screening period until Visit 2 (Randomization) with the exception of diuretics stable for only one week prior to Visit 2 to control symptoms. The investigator must document in the source documents the reason why patient not on target dose per local guidelines
7. Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a
cardiac resynchronization therapy (CRT) consistent with prevailing local or
international CV guidelines (refer also to exclusion #29)
8. Body Mass Index (BMI) < 45 kg/m2 at Visit 1 (Screening)
9. Signed and dated written ICF in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Exclusion criteria
1. Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
2. Heart transplant recipient, or listed for heart transplant
3. Currently implanted left ventricular assist device (LVAD)
001-MCS-40-106-RD-03 (13.0) / Saved on: 05 Aug 2015
4. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation
diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies,
cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic
obstructive cardiomyopathy or known pericardial constriction
5. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial in the investigator's opinion
6. Acute decompensated HF (exacerbation of chronic HF) requiring i.v. diuretics, i.v. inotropes, or i.v. vasodilators, or LVAD within 1 week from discharge to Visit 1
(Screening) and during screening period until Visit 2 (Randomisation)
7. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1(Screening)
8. Untreated ventricular arrhythmia with syncope in patients without ICD documented within the 3 months prior to Visit 1
9. Diagnosis of cardiomyopathy induced by chemotherapy or peripartum within the 12 months prior to Visit 1
10. Symptomatic bradycardia or second or third degree heart block without a pacemaker after adjusting beta-blocker therapy, if appropriate
11. Systolic blood pressure (SBP) ? 180 mmHg at Visit 2. If SBP >150mmHg and
< 100 mmHg at Visit 1 or Visit 2
13. Chronic pulmonary disease requiring home oxygen, oral steroid therapy or
hospitalisation for exacerbation within 12 months, or significant chronic pulmonary
disease in the opinion of the investigator, or primary pulmonary arterial hypertension
14. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST
(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
determined at Visit 1
15. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPI) or
requiring dialysis, as determined at Visit 1
16. Haemoglobin (HgB) < 10 ng/mL, and biopsy Gleason score of ? 6 and clinical stage T1c or T2a)
21. Presence of any other disease than heart failure with a life expectancy of s
opinion, makes them an unreliable trial subject or unlikely to complete the trial
27. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
28. Any other clinical condition that would jeopardise patients safety while participating in this trial, or may prevent the subject from adhering to the trial protocol
29. Implanted cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) within 3 months prior to Visit 1, or if there is an intent to implant ICD or CRT within 3 months of visit 1

Institution
Palmetto
Recruitment Contact
Lauren Nixon
803-434-3800
lauren.nixon@palmettohealth.org

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

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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 Bio Repository Save

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

List of Studies

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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

FLExAbility™ Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Save

Date Added
July 24th, 2018
PRO Number
Pro00077634
Researcher
Jeffrey Winterfield

List of Studies

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Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to show that the FlexAbility™ SE Ablation Catheter is safe and effective in reducing the number of Ventricular Tachycardia (VT) episodes in patients who continue to experience VT despite taking antiarrhythmic medications (medicines to prevent abnormal heart rhythms), or who are unable to take antiarrhythmic medications. Subject should be at least 18 years old. The entire duration of the study will be one year from the ablation procedure and consists of four follow up visits after the ablation procedure.

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

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