Staging Heart Failure With Preserved Ejection Fraction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorI.M. Sechenov First Moscow State Medical University
About this trial
Heart failure with preserved ejection fraction (HFpEF) is considered a systemic condition in which the prevalence of cardiovascular, metabolic, pulmonary and renal conditions determine the extent of cardiac involvement. Numerous attempts have been made to phenotype HFpEF, but patients still lack a clinically and/or prognostically relevant approach.
Progressive cardiac deterioration in HFpEF appears to be associated with a worse prognosis. However, no attempt has been made to classify the extent of cardiac involvement in HFpEF. Investigators proposed the concept of HFpEF staging according to the extent of cardiac involvement identified by transthoracic echocardiography: Stage 1: isolated left ventricular involvement; Stage 2: left atrial myopathy; Stage 3: pulmonary vasculature involvement; and Stage 4: right chambers involvement.
The study aims to investigate the associations between the proposed stages and clinical outcomes in HFpEF patients.
Eligibility criteria
Qualifiers
≥ 40 years of age, male and female
Heart failure symptoms, New York Heart Association (NYHA) II- III
Left ventricular ejection fraction (LVEF) > 50% documented by echocardiography at screening
Rales on chest auscultation or sings of congestion on X-ray/CT scan
Disqualifiers
Any prior measurements of LVEF <50%
Established diagnosis of infiltrative (amyloidosis etc.), hypertrophic cardiomyopathy, muscular dystrophies, complex congenital heart disease, active myocarditis or pericardial constriction
Planned interventions, including major cardiac surgery, percutaneous coronary intervention (PCI), transcatheter aortic valve implantation (TAVI), or implantation of cardiac resynchronization therapy
Elective PCI or atrial fibrillation ablation within 30 days before visit
Trial design
Treatments tested in this trial
- No interventions
Treatment groups
700 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov