Clinical trials: NYHA Class III Heart Failure
Heart Failure, NYHA Class III Heart Failure
NORM-HF Pivotal Study
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF…
- Conditions
- Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure
- Trial name
- NORM-HF (NCT07574593)
- Testing
- IVC Sensor
- Where
- 25 sites in United States
- Volunteers
- 800 people
- Sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)
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.
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
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 III, Heart Failure
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure.
- Trial name
- LOWER-PAP (NCT06783335)
- Testing
- Cordella PA Sensor System, Standard of Care Pharmacologic Therapy
- Where
- United States
- Volunteers
- 2,150 people
- Sponsor
- Endotronix, Inc.
Heart Failure
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication…
- Trial name
- NCT05353166
- Testing
- REGN5381
- Where
- Moldova
- Volunteers
- 59 people
- Sponsor
- Regeneron Pharmaceuticals
Heart Failure, Heart Failure NYHA Class III
Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure
Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the "four-point" questionnaire by Severo and his associates - Heart Failure Questionnaire…
- Conditions
- Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Heart Failure NYHA Class IV
- Trial name
- THETIS (NCT03947853)
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Heart Failure
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care.
- Trial name
- PAS (NCT03970343)
- Testing
- OPTIMIZER Smart System
- Where
- 90 sites in United States
- Volunteers
- 620 people
- Sponsor
- Impulse Dynamics
Heart Failure (NYHA Class III and Ambulatory IV)
Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm…
- Trial name
- RESPOND-CAS (NCT02374801)
- Testing
- SonR automatic optimization feature turned ON ("AV+VV").
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- MicroPort CRM
Hypertension (HTN), NYHA Class III Heart Failure
Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to…
- Conditions
- Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus
- Trial name
- NCT07064525
- Testing
- SPC1001 Low, SPC5002, SPC5003
- Where
- South Korea
- Volunteers
- 252 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Congestive Heart Failure, Heart Failure
AB-1002 in Patients With Class III Heart Failure
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart…
- Conditions
- Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases
- Trial name
- NAN-CS101 (NCT04179643)
- Testing
- 3 x 10e13vg AB-1002
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- AskBio 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
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
Congestive Heart Failure
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device.
- Trial name
- CLEPSYDRA (NCT00957541)
- Testing
- Paradym CRT + Physiological Diagnosis (PhD)
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- ELA Medical, Inc.
Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
Study of JK07 in Patients With Chronic Heart Failure
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
- Trial name
- RENEU-HF (NCT06369298)
- Testing
- JK07
- Where
- 62 sites in United States, Canada and 2 more
- Volunteers
- 282 people
- Sponsor
- Salubris Biotherapeutics Inc
Heart Failure NYHA Class II, Heart Failure NYHA Class III
CardioMEMS HF System Real-World Evidence Post-Approval Study
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
- Trial name
- NCT06306573
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
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 NYHA Class II, Heart Failure NYHA Class III
Step and Walking Pattern From Cardiac Monitor Study
To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor
- Trial name
- SWAN (NCT04971993)
- Testing
- Wearable Cardiac Monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH.
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
- Trial name
- RENEU-PH (NCT07221513)
- Testing
- JK07
- Where
- United States
- Sponsor
- Salubris Biotherapeutics Inc
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study.
- Trial name
- ALLEVIATE-HF (NCT04452149)
- Testing
- Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download, Medication intervention, Not Randomized to Device or Medication Intervention
- Where
- 53 sites in United States
- Volunteers
- 826 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure