Clinical trials: Heart Failure Preserved Ejection Fraction
Pulmonary Hypertension
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
- Trial name
- LEVEL (NCT05983250)
- Testing
- TNX-103
- Where
- 42 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- Tenax Therapeutics, 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
Healthy Volunteers
Multiple-ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Healthy Male Subjects
This is a randomized, single-blind, placebo-controlled study conducted on healthy male subjects at a single study center to assess the safety, tolerability and the pharmacokinetics of AZD9977 following multiple-ascending oral…
- Trial name
- NCT03435276
- Testing
- AZD9977
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Heart Failure With Reduced Ejection Fraction, HFrEF
VisONE Heart Failure Study: Pilot
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system…
- Trial name
- NCT03484780
- Testing
- VisONE ADS
- Where
- 3 sites in Georgia, Ukraine
- Volunteers
- 15 people
- Sponsor
- VisCardia Inc.
Heart Failure With Preserved Ejection Fraction (HFpEF
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve.
- Trial name
- Rebalance-HF (NCT04592445)
- Testing
- Greater Splanchnic Nerve Ablation
- Where
- 26 sites in United States, Georgia
- Volunteers
- 150 people
- Sponsor
- Axon Therapies, Inc.
Heart Failure With Normal Ejection Fraction, Sleep Apnea
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep…
- Trial name
- CAT-PEF (NCT03195660)
- Testing
- ASV Therapy
- Where
- 4 sites in United States, Germany
- Volunteers
- 6 people
- Sponsor
- ResMed
Heart Failure
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood…
- Trial name
- FINEARTS-HF (NCT04435626)
- Testing
- Finerenone (BAY94-8862)
- Where
- 661 sites in United States, Argentina and 35 more
- Volunteers
- 6,016 people
- Sponsor
- Bayer
Heart Failure
A Study to Assess the Reaction of Body for Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects
AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial antagonist and partial agonist in reporter gene assays and has a different interaction pattern with the MR compared to eplerenone.
- Trial name
- NCT03804645
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Heart Failure
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
- Trial name
- NCT01570517
- Testing
- IASD System
- Where
- 3 sites in Australia, Czechia and 1 more
- Volunteers
- 11 people
- Sponsor
- Corvia Medical
Heart Failure With Preserved Ejection Fraction
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.
- Trial name
- SERENADE (NCT03153111)
- Testing
- Macitentan
- Where
- 95 sites in United States, Argentina and 15 more
- Volunteers
- 143 people
- Sponsor
- Actelion
Heart Failure
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Japanese Healthy Participants With Single and Multiple Ascending Dose Administration
AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial antagonist and partial agonist in reporter gene assays and has a different interaction pattern with the MR compared to eplerenone.
- Trial name
- NCT03801967
- Testing
- AZD9977
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Diastolic Heart Failure
Rheos® Diastolic Heart Failure Trial
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.
- Trial name
- NCT00718939
- Testing
- Rheos Baroreflex Activation Therapy System
- Where
- 4 sites in Germany
- Volunteers
- 6 people
- Sponsor
- CVRx, Inc.
Heart Failure, Heart Failure With Preserved Ejection Fraction (HFPEF)
Sodium-Glucose Cotransporter 2 Inhibitor Use in a National Heart Failure Telemonitoring Program
This observational cohort study evaluates temporal trends and determinants of sodium-glucose cotransporter 2 inhibitor (SGLT2i) prescriptions among adults with chronic heart failure enrolled in a nationwide remote monitoring…
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Reduced Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
- Trial name
- REMOTE-HF (NCT07022379)
- Testing
- SGLT2 Inhibitor Use
- Where
- France
- Volunteers
- 13,660 people
- Sponsor
- Satelia
Heart Failure
REALIsM-HF Pilot Study
The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart…
- Trial name
- REALIsM-HF (NCT03507439)
- Testing
- AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor, DynaPort Move Monitor
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 27 people
- Sponsor
- Bayer
Heart Failure
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).
- Trial name
- NCT06991257
- Testing
- Low Dose PF-07328948, Medium Dose PF-07328948, High Dose PF-07328948
- Where
- 150 sites in United States, Argentina and 12 more
- Volunteers
- 620 people
- Sponsor
- Pfizer
Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the…
- Trial name
- SERENADE OL (NCT03714815)
- Testing
- macitentan 10 mg
- Where
- 44 sites in United States, Argentina and 13 more
- Volunteers
- 91 people
- Sponsor
- Actelion
Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims.
- Trial name
- NCT06671314
- Where
- United States
- Volunteers
- 42,494 people
- Sponsor
- Novartis
Heart Failure Low Output, Heart Failure
The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved ejection fraction)
- Trial name
- PRELIEVE (NCT03030274)
- Testing
- Occlutech AFR device
- Where
- 26 sites in Belgium, Germany and 1 more
- Volunteers
- 106 people
- Sponsor
- Occlutech International AB
Heart Failure With Preserved Ejection Fraction
A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF…
- Trial name
- PARALLAX (NCT03066804)
- Testing
- sacubitril/valsartan, Enalapril, Valsartan
- Where
- 380 sites in United States, Argentina and 30 more
- Volunteers
- 2,572 people
- Sponsor
- Novartis Pharmaceuticals