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
This trial does not accept healthy volunteersQualifiers
≥ 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 population
Patients with HFpEF, male and female, 40 years old and over who meet eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No interventions
Other interventionNo interventions
Treatment groups
700 Participants
are divided into 4 treatment groupsGroup A: HFpEF Stage 1: Isolated left ventricle involvement1 intervention
Group B: HFpEF Stage 2: Left atrial myopathy1 intervention
Group C: HFpEF Stage 3: Pulmonary vasculature involvement1 intervention
Group D: HFpEF Stage 4: Right chambers involvement1 intervention
Trial outcomes
Primary outcomes
1
Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation
Measured in months
Time frame
From randomisation to end of 12 months follow-upSecondary outcomes
1
Number of all-cause deaths, Cardiovascular (CV) deaths, HF hospitalisations or urgent HF visits
Measured as count of event
Time frame
From randomisation to end of 12 months follow-up2
Time to occurrence of all-cause death
Measured in months
Time frame
From randomisation to end of 12 months follow-up3
Time to occurrence of CV death
Measured in months
Time frame
From randomisation to end of 12 months follow-up4
Time to first HF hospitalisation or urgent HF Visit
Measured in months
Time frame
From randomisation to end of 12 months follow-upSponsors and contacts
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Source ClinicalTrials.gov
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