Clinical trials: Heart Failure NYHA Class III
NYHA Class III Heart Failure
Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St.
- Trial name
- NCT02939053
- Testing
- SOZO
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- ImpediMed Limited
Congestive Heart Failure
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to…
- Trial name
- NCT02388464
- Testing
- MTP-131
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Failure NYHA Class III
SIRONA 2 Trial Heart Failure NYHA Class III
This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who…
- Trial name
- NCT04012944
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 81 people
- Sponsor
- Endotronix, Inc.
Heart Failure, Congestive
Study of DITPA in Patients With Congestive Heart Failure
This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low serum T3.
- Trial name
- NCT00103519
- Testing
- DITPA (3,5-diiodothyropropionic acid)
- Where
- 22 sites in United States
- Volunteers
- 86 people
- Sponsor
- Titan Pharmaceuticals
Chronic Heart Failure
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with…
- Trial name
- RELAX-Cardio (NCT02625922)
- Testing
- Serelaxin
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Congestive
ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and…
- Trial name
- NCT00283361
- Testing
- ZP120, I.v. catherization, 6-minutes walk performance
- Where
- 22 sites in United States
- Volunteers
- 130 people
- Sponsor
- Zealand Pharma
Congestive Heart Failure
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
The purpose of this study is to determine the effect of two different doses of MCC-135, once daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects with congestive heart failure.
- Trial name
- NCT00050076
- Testing
- MCC-135
- Where
- 53 sites in United States
- Volunteers
- 204 people
- Sponsor
- Takeda
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
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
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 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.
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
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, 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
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