Clinical trials: Heart Failure
Heart Failure
Detect Fluid Early From Intra-thoracic Impedance Monitoring
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
- Trial name
- DEFEAT-PE (NCT00916929)
- Testing
- Impedance Monitoring Feature
- Where
- 34 sites in United States
- Volunteers
- 162 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as…
- Trial name
- NCT01439009
- Testing
- Tolvaptan
- Where
- 8 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy
Ranolazine Implantable Cardioverter-Defibrillator Trial
The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs).
- Conditions
- Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
- Trial name
- RAID (NCT01215253)
- Testing
- Ranolazine
- Where
- 90 sites in United States, Canada
- Volunteers
- 1,012 people
- Sponsor
- University of Rochester
Heart Failure, Ventricular Dyssynchrony
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication…
- Trial name
- EchoCRT (NCT00683696)
- Testing
- Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
- Where
- 122 sites in United States, Australia and 15 more
- Volunteers
- 1,680 people
- Sponsor
- Biotronik, Inc.
Myocardial Infarction
Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement
One emerging concept is that some form of injury or inflammation is a prerequisite for the success of circulating-cell participation in differentiated tissue structure and function.
- Trial name
- NCT00154466
- Testing
- cardiac rehabilitation
- Where
- Taiwan
- Volunteers
- 58 people
- Sponsor
- National Taiwan University Hospital
Heart Failure
The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure patients suggested that omega 3 may lower the risk…
- Trial name
- NCT00944229
- Testing
- LOVAZA (Omega-3)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Columbia University
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Dyspnea
Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is…
- Trial name
- TACTICS-HF (NCT01644331)
- Testing
- Tolvaptan
- Where
- 18 sites in United States
- Volunteers
- 257 people
- Sponsor
- Duke University
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
Heart Failure, Heart Failure, Systolic
Hemodynamic-GUIDEd Management of Heart Failure
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for…
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure NYHA Class II
- Trial name
- GUIDE-HF (NCT03387813)
- Testing
- CardioMEMS™ HF System
- Where
- 129 sites in United States, Canada
- Volunteers
- 2,358 people
- Sponsor
- Abbott Medical Devices
Heart Failure NYHA Class III
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
- Trial name
- PROACTIVE-HF (NCT04089059)
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 74 sites in United States, Belgium and 1 more
- Volunteers
- 738 people
- Sponsor
- Endotronix, Inc.
Chronic Heart Failure (CHF)
Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study
The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center.
- Trial name
- CASA (NCT01581008)
- Testing
- Collaborative Care to Alleviate Symptoms and Adjust to Illness, Psychospiritual
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- VA Office of Research and Development
Heart Failure
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
- Trial name
- DOAC LVAD (NCT04865978)
- Testing
- Apixaban, Warfarin, LVAD implant
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Palak Shah
Obesity, Heart Failure
Sex and Obesity: Effects on Heart Failure Study
Sex has a major impact on myocardial metabolism and blood flow. In those without heart failure men's hearts tend to use proportionally more glucose and women's hearts use more fat and have higher blood flow.
- Trial name
- NCT00776035
- Testing
- PET (Positron Emission Tomography), Echocardiogram, ^15O-water
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Washington University School of Medicine
Heart Failure, Systolic, Heart Failure
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
- Trial name
- NCT03374891
- Testing
- Educational video and/or handout
- Where
- United States
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Hypertension Pulmonary Secondary, Heart Failure, Right Sided
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
- Conditions
- Hypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
- Trial name
- HELP (NCT03541603)
- Testing
- Levosimendan
- Where
- 16 sites in United States
- Volunteers
- 44 people
- Sponsor
- Tenax Therapeutics, Inc.
Hypertension, Diabetes
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
- Trial name
- EFFORT (NCT00829296)
- Testing
- nebivolol, Metoprolol
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Heart Failure
Attain Performa(TM) Quadripolar Lead Study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure.
- Trial name
- NCT01751022
- Testing
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Where
- 121 sites in United States, Australia and 25 more
- Volunteers
- 1,202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure