Prediction of the Development of Heart Failure With Preserved Ejection Fraction (PREDICT-HFpEF)

Heart Center Leipzig - University Hospital

Status: Unknown

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Diagnostic Test: Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016

Study type: Observational

Funder types: Other

Identifiers

NCT04894968

PREDICT-HFpEFv1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At timepoint of inclusion in the LIFE-Heart study normal left ventricular ejection fraction (≥ 50%)
• At timepoint of inclusion in the LIFE-Heart study normal NT-proBNP (< 125 ng/l)

Exclusion criteria

• At timepoint of inclusion in the LIFE-Heart study acute coronary syndrom

  1. Troponine elevation above 14 pg/ml as well as coronary intervention, or isolated troponine elevation above 50 pg/ml in the absence of a coronary intervention
  2. No troponine elevation but coronary intervention
  3. Creatine kinase > 0.41 µmol/l*s and Creatine kinase to Creatine kinase-MB ration >6% or Creatine kinase-MB > 0.82 µmol/l*s

• At timepoint of inclusion in the LIFE-Heart study missing data on left ventricular ejection fraction

• At timepoint of inclusion in the LIFE-Heart study missing NT-proBNP measurement

• At timepoint of inclusion in the LIFE-Heart study missing data on echocardiographic diastolic function and structural alterations of the left ventricle

• At timepoint of inclusion in the LIFE-Heart study relevant valvular heart disease (including relevant aortic stenosis, mitral- and/or tricuspid regurgitation, congenital heart disease, mitral stenosis)