Staging Heart Failure With Preserved Ejection Fraction

NCT06931015 | Not Yet Recruiting

• 1 other identifier: 05-22
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Cardiovascular Diseases; Heart Failure

Keywords

HFpEF; Staging; Classification; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation

  Measured in months

  From randomisation to end of 12 months follow-up

Secondary Outcomes (4)

• Number of all-cause deaths, Cardiovascular (CV) deaths, HF hospitalisations or urgent HF visits

  From randomisation to end of 12 months follow-up

• Time to occurrence of all-cause death

  From randomisation to end of 12 months follow-up

• Time to occurrence of CV death

  From randomisation to end of 12 months follow-up

• Time to first HF hospitalisation or urgent HF Visit

  From randomisation to end of 12 months follow-up

Study Arms (4)

HFpEF Stage 1: Isolated left ventricle involvement

Established if patients meet the criteria of Stage 1, according to the proposed classification, which are: * LVMI \>115 g/m2 in men/ and \>95 g/m2 in women or * Relative wall thickness (RWT) \>0.42 or * Elevated LV filling pressures at rest (E/e' \>9) doi.org/10.15420/ecr.2024.31

Other: No interventions

HFpEF Stage 2: Left atrial myopathy

Stage 1 criteria, plus: * LAVI \>34 ml/m2, if sinus rhythm or * AF

Other: No interventions

HFpEF Stage 3: Pulmonary vasculature involvement

Stage 1-2 criteria, plus: * Pulmonary artery systolic pressure (PASP) \>35 mmHg and/or * Tricuspid regurgitation (TR) velocity \>2.8 m/s

Other: No interventions

HFpEF Stage 4: Right chambers involvement

Stage 1-3 criteria, plus: * Fractional area change (FAC) \<35% or * S' \<9.5 cm/s and/or * Tricuspid annular plane systolic excursion (TAPSE) \<17 mm and/or * Right atria (RA) volume index (\>39 ml/m2 in men/ \>33 ml/m2 for women)

Other: No interventions

Interventions

No interventions OTHER

No interventions

HFpEF Stage 1: Isolated left ventricle involvement; HFpEF Stage 2: Left atrial myopathy; HFpEF Stage 3: Pulmonary vasculature involvement; HFpEF Stage 4: Right chambers involvement

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HFpEF, male and female, 40 years old and over who meet eligibility criteria.

You may qualify if:

• ≥ 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
• One of the following scenarios:
• A) At screening, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF) and echocardiographic criteria see #5
• B) Previously confirmed HFpEF in combination with a history of hospitalization for HFpEF decompensation \>30 days before screening defined as the presence of dyspnea and 2 of the following:
• Rales on chest auscultation or sings of congestion on X-ray/CT scan
• Peripheral Oedema
• Elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF)
• Structural and/or functional abnormalities of heart, at least one of the following:
• Left atrial volume index (LAVI) \>34 mL/m2 (if AF \>40 mL/m2)
• Left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females
• Relative wall thickness \> 0.42
• E/e' ratio at rest \>9
• Stable doses of oral loop diuretics, if prescribed

You may not qualify if:

• 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
• Moderate and severe valve stenosis and more than mild primary valve regurgitation
• Acute myocardial infarction in the last 3 months, cardiac surgery, pulmonary embolism or cerebrovascular accident within the last six months
• Candidates for heart transplantation
• Secondary hypertension
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
• Any active cancer
• Infective endocarditis
• Alcoholic cirrhosis
• End-stage kidney disease
• Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

A Shchendrygina

Moscow, 119415, Russia

Location

Related Links

• The publication which define the concept of Staging Heart Failure with Preserved Ejection Fraction by Assessing Cardiac Chamber Involvement

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Anastasia Shchendrygina

  Sechenov University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Shchendrygina

CONTACT

+79262309207; a.shchendrygina@gmail.com

Svetlana Rachina

CONTACT

rachina_s_a@staff.sechenov.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): April 13, 2028
• Study Completion (Estimated): December 13, 2028
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)