Overview
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
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.
Eligibility
Inclusion Criteria:
Clinical criteria:
- Age >18 years
- Written informed consent
- HF with moderate to severe symptoms NYHA II or III
- Hospitalization or emergency room visit for HF or symptom relief with diuretics
- Sinus rhythm or AF
Echocardiographic criteria:
- LVEF >0.40
- 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:
- BNP >31ng/L or NT-pro-BNP>125ng/L if sinus rhythm
- BNP >75ng/L or NT-pro-BNP>300ng/L if atrial fibrillation
Exclusion Criteria:
- Patients unwilling or unable to sign informed consent
- Patients with a pacemaker or ICD
- Indication for ICD therapy according to the ESC guidelines
- Life expectancy of less than one year
- Significant coronary artery disease or myocardial infarction < 3 months
- Complex congenital heart disease
- Pregnancy