Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Recruiting

• Conditions: Heart Failure, Diastolic

• Registration Number: NCT05479669
• Lead Sponsor: University Medical Center Groningen

Brief 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

Detailed 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 Timeline

• Study Start: 2022-03-29
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-01-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Clinical criteria:

1. Age >18 years
2. Written informed consent
3. HF with moderate to severe symptoms NYHA II or III
4. Hospitalization or emergency room visit for HF or symptom relief with diuretics
5. Sinus rhythm or AF

Echocardiographic criteria:

1. LVEF >0.40
2. Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s).

Biomarker criteria:

1. BNP >31ng/L or NT-pro-BNP>125ng/L if sinus rhythm
2. BNP >75ng/L or NT-pro-BNP>300ng/L if atrial fibrillation

Exclusion Criteria

1. Patients unwilling or unable to sign informed consent
2. Patients with a pacemaker or ICD
3. Indication for ICD therapy according to the ESC guidelines
4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction < 3 months
6. Complex congenital heart disease
7. Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined endpoint of all-cause mortality and hospitalization for heart failure	5 years	The incidence of the combined endpoint of all-cause mortality and first heart failure hospitalization

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands