Clinical trials: Heart Failure NYHA Class III
NYHA Class III Heart Failure, NYHA Class IV Heart Failure
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
- Trial name
- FIX-HF-5C (NCT01381172)
- Testing
- Optimizer System, No intervention: Optimal medical therapy
- Where
- 42 sites in United States, Czechia and 1 more
- Volunteers
- 160 people
- Sponsor
- Impulse Dynamics
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure
Individuals with chronic heart failure need a "safe and effective" exercise program that could enhance their quality of life. In this study, we examined whether an experimental exercise program of autonomous walking and…
- Trial name
- NCT01560871
- Testing
- High-intensity IMT plus walking, Low-intensity IMT plus walking
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Texas Woman's University
Heart Failure NYHA Class II, Heart Failure NYHA Class III
A Study to Improve Physician-Youth Communication and Medical Decision Making
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- CHATT (NCT05835063)
- Testing
- We Chatt communication tool, Usual/standard care
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Michigan
Heart Failure
C-Pulse® System European Multicenter Study
The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
- Trial name
- OPTIONS-HF (NCT01872949)
- Where
- 8 sites in Austria, Germany
- Volunteers
- 15 people
- Sponsor
- Nuwellis, Inc.
Congestive Heart Failure
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers.
- Trial name
- NCT00063687
- Testing
- Oxypurinol
- Where
- 4 sites in United States
- Volunteers
- 400 people
- Sponsor
- Advanz Pharma
Heart Failure NYHA Class I, Heart Failure NYHA Class II
Future Patient - Telerehabilitation of Heart Failure Patients
The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.
- Conditions
- Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT03388918
- Testing
- Telerehabilitation
- Where
- Denmark
- Volunteers
- 140 people
- Sponsor
- Aalborg University
Chronic Heart Failure, Heart Failure NYHA Class II
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of <40% of normal cardiac…
- Conditions
- Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT01669395
- Testing
- Early homebased rehabilitation after hospital admission, Usual care
- Where
- Denmark
- Volunteers
- 80 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
Heart Failure NYHA Class II, Heart Failure NYHA Class III
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2…
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure
- Trial name
- NCT05934487
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 48 sites in United States, Belgium and 1 more
- Volunteers
- 1,750 people
- Sponsor
- Endotronix, Inc.
Heart Failure
C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily…
- Trial name
- NCT01176370
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Nuwellis, Inc.
Tricuspid Regurgitation, Heart Failure NYHA Class III
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability.
- Conditions
- Tricuspid Regurgitation, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT02537769
- Testing
- Left ventricular assist device (LVAD), Tricuspid Valve Repair (TVR)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Heart Failure, Congestive
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing…
- Trial name
- CHAMPION (NCT00531661)
- Testing
- HF Pressure Measurement System
- Where
- United States
- Volunteers
- 550 people
- Sponsor
- CardioMEMS
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Remission From Stage D Heart Failure
The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery…
- Trial name
- RESTAGE-HF (NCT01774656)
- Testing
- Pharmacological Treatment
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Louisville
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
- Trial name
- NCT02645539
- Testing
- intravascular ventricular assist system (iVAS)
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- NuPulseCV
NYHA Class III Heart Failure
Bioimpedance Spectroscopy Compared to CardioMEMS™
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
- Trial name
- NCT02857231
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- ImpediMed Limited
Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in…
- Trial name
- BRIGHTEN-HF (NCT07209098)
- Testing
- Cardiac Contractility Modulation (CCM)
- Where
- United States
- Volunteers
- 4,200 people
- Sponsor
- Impulse Dynamics
Heart Failure, Heart Failure NYHA Class II
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF < 50%…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- Trial name
- BENEFIT-HF (NCT07232030)
- Testing
- Barostim System, Usual care medical management
- Where
- 20 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- CVRx, Inc.
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
The goal of this observational study is to learn about SGLT2 inhibition medications in patients with symptomatic heart failure who are clinically prescribed FDA-approved SGLT2 inhibitors.
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure
- Trial name
- EMAS-HF (NCT05885607)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Pennsylvania
Heart Failure, Heart Failure NYHA Class II
Heart Failure Management for Patient With CIED Remotely Monitored
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- PROACT-HF (NCT07247032)
- Testing
- SmartSignalHF, HF RM standard of care
- Where
- France
- Volunteers
- 1,132 people
- Sponsor
- Implicity
Heart Failure, Heart Transplantation
Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)
End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before…
- Conditions
- Heart Failure, Heart Transplantation, Heart-Assist Devices
- Trial name
- MEVADE (NCT03105726)
- Volunteers
- 224 people
- Sponsor
- Joe Elie Salem
Heart Failure
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and…
- Trial name
- TRI-V (NCT00746135)
- Testing
- Device Implantation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices