Clinical trial NCT04894968: Prediction of the Development of Heart Failure With Preserved Ejection Fraction
Official title: Identifying Predictors for the Development and Uphold of Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Heart failure with preserved ejection fraction
Heart failure
Adiposity
Inflammation
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without evident heart failure with preserved ejection fraction that were included in the prospective cohort study: LIFE-Heart

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Heart failure with preserved ejection
timeFrame: At timepoint of inclusion
Secondary outcomes:
measure: Occurence of major adverse cardiovascular events
timeFrame: 24-months after study inclusion
measure: Changes in vascular status
timeFrame: At timepoint of inclusion
measure: Changes in organ function
timeFrame: At timepoint of inclusion
measure: All-cause death
timeFrame: Yearly, after study enrollment up to ten years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig at Leipzig University
state: Saxony
Study officials:
References:
citation: Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lucke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.
citation: Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.