Clinical Trials Logo

Clinical Trial Summary

Heart failure (HF) with a left ventricular ejection fraction (LVEF) >0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF >0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile


Clinical Trial Description

Objective: To assess the risk profile associated with the combined endpoint of all-cause mortality and HF hospitalizations in HF patients with LVEF >0.40. Study design: Single-center, prospective, study. Study population: We aim 200 patients with symptomatic heart failure (NYHA class II-III), and a recent HF hospitalization, emergency room visit or symptom relief with diuretics who have a left ventricular ejection fraction >0.40, echocardiographic evidence of left atrial enlargement or left ventricular hypertrophy, and elevated concentrations of BNP or NT-proBNP. Study procedures: All patients will undergo echocardiography, cardiac magnetic resonance (CMR) imaging, Holter recording and blood sampling at inclusion. The 99mTc-HDP scan is optional.There is no control group. Total follow up: Up to five years. Main study endpoint: incidence of the combined endpoint of all-cause mortality and HF hospitalizations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05479669
Study type Observational
Source University Medical Center Groningen
Contact Michiel Rienstra, MD PhD
Phone 0031503612878
Email m.rienstra@umcg.nl
Status Recruiting
Phase
Start date March 29, 2022
Completion date January 1, 2031

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04573166 - Personalized Atrial Septostomy for Heart Failure N/A
Recruiting NCT02425371 - Optimized Management of Comorbidity in Heart Failure With Preserved Ejection Fraction in the Elderly (>60 Years) Phase 3
Terminated NCT03312387 - Muscle, Essential Amino Acids, and eXercise in Heart Failure N/A
Completed NCT05475028 - Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
Recruiting NCT04950218 - The Psoriasis Echo Study
Completed NCT02334891 - Kyoto Congestive Heart Failure Study
Recruiting NCT05577819 - Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF N/A
Completed NCT05139472 - Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction Phase 3
Recruiting NCT04682704 - The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function N/A
Completed NCT03924479 - Respiratory Muscle Function in Heart Failure N/A
Recruiting NCT03830957 - Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker N/A
Completed NCT02589977 - Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF Phase 4
Completed NCT02946476 - Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients N/A
Recruiting NCT04179643 - NAN-101 in Patients With Class III Heart Failure Phase 1
Recruiting NCT05425459 - RESPONDER-HF Trial N/A
Completed NCT04940312 - MyoMobile Study: App-based Activity Coaching in Patients With Heart Failure and Preserved Ejection Fraction
Recruiting NCT04602338 - Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging
Completed NCT03240237 - CCM in Heart Failure With Preserved Ejection Fraction N/A
Recruiting NCT05887271 - A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction Phase 2/Phase 3
Completed NCT02408003 - Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support. N/A