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.
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.
Study Type
OBSERVATIONAL
Enrollment
800
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
Heart Center Leipzig at Leipzig University
Leipzig, Saxony, Germany
RECRUITINGHeart failure with preserved ejection
Presence of heart failure with preserved ejection fraction according to the European Society of Cardiology 2016 criteria
Time frame: At timepoint of inclusion
Occurence of major adverse cardiovascular events
Patients will be followed-up after their inclusion in the PREDICT-HFpEF study for the occurence of major adverse cardiovascular events using regular telephone interviews.
Time frame: 24-months after study inclusion
Changes in vascular status
Patients vascular status will be screened at study inclusion (e.g. intima media thickness) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study
Time frame: At timepoint of inclusion
Changes in organ function
Patients liver, as well as renal function as assessed by laboratory status will be screened at study inclusion (e.g. creatinine, bilirubine, Gamma-glutamyltransferase) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study
Time frame: At timepoint of inclusion
All-cause death
Patients will be screened on a yearly basis for the occurence of all-cause mortality
Time frame: Yearly, after study enrollment up to ten years
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