The "RADIANCE II" Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension Save

Date Added
October 9th, 2018
PRO Number
Pro00081841
Researcher
Thomas Todoran

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Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the FDA. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries). The ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels.

Participants will stop taking hypertensive medication before the procedure and up to two months after the procedure. Participants will be randomized to the procedure or control and will be followed for 36 months. At the six month follow-up appointment, participants will learn whether they had the procedure or not. Those who did not receive the procedure can opt in to have the procedure in the future.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
8438765009
paladugc@musc.edu

Detecting the Pathophysiology that Drives Fontan-associated Liver Disease Save

Date Added
October 5th, 2018
PRO Number
Pro00077466
Researcher
Joshua Kurtz

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Keywords
Adolescents, Cardiovascular, Children's Health
Summary

The purpose of this study is to evaluate causes and risk factors for liver disease in those whom have 1) undergone the Fontan procedure or 2) whom have dilated cardiomyopathy.

Participants in this study will have a blood sample collected, undergo cardiac magnetic resonance imaging (CMR), a liver magnetic resonance imaging (MRI), shear wave ultrasound elastography (SWE), echocardiography, liver Doppler ultrasound, and an exercise stress test. Participants medical records will be reviewed to collect information on previous medical procedures. Participation is complete once all imaging studies and blood sample have been collected.

This is not a treatment study; if one chooses not to participate, s/he will continue to undergo regularly scheduled clinical procedures.

Institution
MUSC
Recruitment Contact
Joshua Kurtz
843-834-0972
kurtzj@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

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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

Human Samples Biorepository Save

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

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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

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane

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Keywords
Cancer, Cancer/Genitourinary, Cardiovascular, Drug Studies, Prostate
Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

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

An Open-Label Extension and Safety Monitoring Study of Patients with Symptomatic Transthyretin Cardiomyopathy Who Have Completed the Phase II Study AG10-201 Save

Date Added
July 24th, 2018
PRO Number
Pro00079020
Researcher
Daniel Judge

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Keywords
Cardiovascular
Summary

The purpose of this research is to test a new experimental drug called "AG10" made by Eidos Therapeutics, to find out if this new drug is safe and if it works to help patients with Amyloidosis Cardiomyopathy. This is a follow up of the AG10-201 study in which participants were randomized to either study drug or placebo. It is only open to participants who completed the AG10-201 study. It will consist of 4 clinic visits and take less than three months for the participants to complete.

Institution
MUSC
Recruitment Contact
Anita Smalls
843-876-5011
smaani@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

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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

Hemodynamic-GUIDEd Management of Heart Failure Save

Date Added
June 12th, 2018
PRO Number
Pro00075937
Researcher
Michael Craig

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Keywords
Cardiovascular, Heart
Summary

Heart failure affects over one million Americans and thousands of new cases are diagnosed each year. This syndrome tends to be progressive and is associated with an increased risk for hospitalizations and possbile death. The CardioMEMS™ HF System is an FDA approved device for individuals with class III heart failure. The system is placed in your heart during a short procedure. Following placement, your doctor is able to monitor the pressures in your heart from the comfort of your own home.The GUIDE-HF study will investigate to determine if the device is effective in individuals with class II, III, or IV heart failure with elevated labs and/or those who have had prior heart failure hospitalizations. During the study, patients will be seen 6 times in our research clinic. During these visits the study staff will ask you to fill out questionnaires, measure your vital signs (blood pressure, heart rate, weight), perform a 6 minute hall walk, draw blood to look at your heart function, and review medications. The device is permanent after implant.

Institution
MUSC
Recruitment Contact
Lindsey Stewart
8437921238
stew@musc.edu

VITROS® Immunodiagnostic Products hs Troponin I US Sample Collection Protocol Save

Date Added
May 8th, 2018
PRO Number
Pro00076320
Researcher
Gary Headden

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Keywords
Cardiovascular, Heart, Non-interventional
Summary

Roughly 8-10 million patients complaining of chest pain come to an Emergency Department (ED) annually in the United States. Quickly determining if you are having a heart attack is critical for improving your chances of survival. Cardiac troponin is a protein that is used as a biomarker (biological marker) to indicate damage to the heart muscle. Cardiac troponin lab tests that are currently used in the United States do not have the ability to detect low levels of troponin. There are more sensitive troponin tests that are primarily used outside the US, that are able to detect lower levels of cardiac troponin within 90-180 minutes instead of 5 or 6 hours. This allows for the early identification of individuals at a higher risk for heart damage and these patients benefit from early diagnosis and treatment. Delaying the treatment of a heart attack increases the chance of dying or being permanently disabled. This study will collect blood samples from people coming to the Emergency Department complaining of chest pain in order to measure this troponin lab test's ability to accurately detect troponin levels.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@musc.edu

Multiple cArdiac seNsors for mAnaGEment of Heart Failure Save

Date Added
May 8th, 2018
PRO Number
Pro00075530
Researcher
Michael Gold

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

Cardiac implantable electronic devices (Implantable Cardioverter Defibrillators (ICD),cardiac resynchronization therapy (CRT)) with sensors have been used to develop Heart Failure diagnostics which indicate early changes leading up to hospitalizations. The study is testing a feature that can help predict when your heart failure is getting worse. The feature is called HeartLogic™ Heart Failure Diagnostic Service, or simply HeartLogic.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922944
adamsde@musc.edu

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