NCT04894968

Prediction of the Development of Heart Failure With Preserved Ejection Fraction

Identifying Predictors for the Development and Uphold of Heart Failure With Preserved Ejection Fraction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Patients that were initially included in another prospective cohort study (LIFE-Heart study) and did not show evident heart failure at that timepoint, will be followed-up approximately 7-years after their initial inclusion in the LIFE-Heart study. Patients will be screened for the development of HFpEF and characterized with thorough clinical as well as laboratory assessment. Patients will be classified according to the presence of absence of heart failure and predictors for the development will be identified by using measurements taken at their initial inclusion in the LIFE-Heart study.

Detailed description

Heart failure with preserved ejection fraction (HFpEF) is associated with severe morbidtiy and mortality. Yet, little is known about factors leading to the development of HFpEF investigated in a longitudinal fashion. The PREDICT-HFpEF study aims to adress this open question. Patients that were initially included in a large cohort study (LIFE-Heart study) approximately 7-years ago, that underwent thorough clinical, laboratory and echocardiographic assessment, and did not show evidence of heart failure at the present time point will be included in the current study. Patients will be screened for the development of HFpEF or other forms of heart failure (e.g. heart failure with reduced ejection fraction) and will again undergo thorough clinical, laboratory and echocardiographic assessment. Initially measured biomarkers (including clinical data, lab-charts, ECG recordings and echocardiography) will be used to predict the development of HFpEF in this cohort at cardiovascular risk.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016	Patient will be screened for the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016. This requires patients to fulfill all of the four criteria listed below: 1. Symptoms of heart failure (e.g. dyspnea on extertion) 2. Preserved ejection fraction (Left ventricular ejection fraction ≥50% 3. NT-proBNP ≥125 pg/mL 4. Echocardiographic signs for structural heart disease or diastolic dysfunction (at least one of the criteria below) * Left atrial volume index \>34 mL/m² * Left ventricular mass index ≥115 g/m² for males or ≥95 g/m² for females * E/e' ≥13 * Septal e' \<9 cm/s

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-05-01
• Completion: 2022-11-01
• First posted: 2021-05-20
• Last updated: 2022-03-17

Locations

1 site across 1 country: Germany