Clinical trials: Heart Failure With Preserved Ejection Fraction (HFPEF)
- Condition Heart Failure With Preserved Ejection Fraction (HFPEF)
- Funder type Industry (pharma, biotech, devices)
Heart Failure, Heart Failure, Diastolic
RESPONDER-HF Trial
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
- Trial name
- NCT05425459
- Testing
- Corvia Atrial Shunt System / IASD System II, Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
- Where
- 61 sites in United States, Australia and 5 more
- Volunteers
- 750 people
- Sponsor
- Corvia Medical
Heart Failure
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart…
- Trial name
- NCT01951638
- Testing
- Vericiguat (BAY1021189) (1.25 mg), Vericiguat (BAY1021189) (5 mg)
- Where
- 158 sites in United States, Australia and 23 more
- Volunteers
- 477 people
- Sponsor
- Bayer
Heart Failure With Preserved Ejection Fraction
A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF.
- Trial name
- CAPACITY-HFpEF (NCT03254485)
- Testing
- IW-1973
- Where
- 62 sites in United States, Canada
- Volunteers
- 196 people
- Sponsor
- Akebia Therapeutics
Type 2 Diabetes, Diabetic Cardiomyopathies
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability
- Conditions
- Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT04826159
- Testing
- IMB-1018972
- Where
- United Kingdom
- Volunteers
- 49 people
- Sponsor
- Imbria Pharmaceuticals, Inc.
Hypertension, Pulmonary
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.
- Trial name
- CADENCE (NCT04945460)
- Testing
- Sotatercept 0.3 mg/kg, Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
- Where
- 119 sites in United States, Belgium and 10 more
- Volunteers
- 165 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Pulmonary Hypertension Associated With HFpEF
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular…
- Trial name
- LEVEL-2 (NCT07288398)
- Testing
- TNX-103
- Where
- 140 sites in United States, Argentina and 13 more
- Volunteers
- 540 people
- Sponsor
- Tenax Therapeutics, Inc.
Heart Failure With Preserved Ejection Fraction (HFpEF)
An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.
This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).
- Trial name
- NCT03909295
- Testing
- LCZ696
- Where
- 17 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF
Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement.
- Conditions
- Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
- Trial name
- NCT07598760
- Testing
- Moderato Plus device with Cardiac Neuromodulation Therapy
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- BackBeat Medical Inc
Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
Global Prevalence of ATTR-CM in Participants With HFpEF
This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved…
- Trial name
- NCT04424914
- Testing
- Scintigraphy
- Where
- 51 sites in United States, Canada and 6 more
- Volunteers
- 347 people
- Sponsor
- Pfizer
Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF)
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.
- Trial name
- NCT04847557
- Testing
- Tirzepatide
- Where
- 146 sites in United States, Argentina and 8 more
- Volunteers
- 731 people
- Sponsor
- Eli Lilly and Company
Heart Failure With Preserved Ejection Fraction (HFpEF)
A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers
This is an open-label, non-randomized, fixed sequence study conducted at a single study center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with…
- Trial name
- NCT03843060
- Testing
- AZD9977, Itraconazole
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Heart Failure With Preserved Ejection Fraction (HFpEF)
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
- Trial name
- NCT06560762
- Testing
- STM01
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Secretome Therapeutics
Heart Failure With Preserved Ejection Fraction
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with…
- Trial name
- ENDEAVOR (NCT04986202)
- Testing
- AZD4831
- Where
- 171 sites in United States, Australia and 16 more
- Volunteers
- 711 people
- Sponsor
- AstraZeneca
Heart Failure, Preserved Ejection Fraction
Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure and Preserved Ejection Fraction
The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting.
- Trial name
- NCT07047508
- Volunteers
- 3,000 people
- Sponsor
- Boehringer Ingelheim
MASH - Metabolic Dysfunction-Associated Steatohepatitis, Heart Failure With Preserved Ejection Fraction (HFPEF)
Resmetirom in Patients With MASH and HFpEF
This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis…
- Trial name
- NCT07830758
- Testing
- Resmetirom
- Where
- 5 sites in United States
- Volunteers
- 90 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Heart Failure
Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.
A randomized, double-blind, placebo-controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will be conducted at approximately 15 sites in 5 countries.
- Trial name
- SATELLITE (NCT03756285)
- Testing
- AZD4831
- Where
- 13 sites in United States, Denmark and 3 more
- Volunteers
- 41 people
- Sponsor
- AstraZeneca
Congestive Heart Failure
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and…
- Trial name
- NCT03163030
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- India
- Volunteers
- 52 people
- Sponsor
- Cyberonics, Inc.
Heart Failure, Pulmonary Hypertension
Rivet PVS Therapy in Group 2 PH-HFpEF
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with…
- Trial name
- NCT05205265
- Testing
- Rivet Shunt
- Where
- 3 sites in United States
- Sponsor
- NXT Biomedical
Heart Failure With Preserved Ejection Fraction
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and…
- Trial name
- EMBARK-HFpEF (NCT04766892)
- Testing
- mavacamten
- Where
- 21 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure With Preserved Ejection Fraction (HFpEF)
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days…
- Trial name
- PARAGLIDE-HF (NCT03988634)
- Testing
- sacubitril/valsartan, valsartan
- Where
- 97 sites in United States, Canada
- Volunteers
- 467 people
- Sponsor
- Novartis Pharmaceuticals