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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Diagnostic test: Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Philipp Lurz, MD, PhD; Phone Number: 0341865252022; Email: philipp.lurz@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • Heart Center Leipzig at Leipzig University
      • Contact: Philipp Lurz, MD, PhD; Phone Number: +49341865252022; Email: Philipp.Lurz@medizin.uni-leipzig.de
      • Contact: Maximilian von Roeder, MD; Phone Number: +49341865252517; Email: maximilian.vonroeder@medizin.uni-leipzig.de
      • Principal Investigator: Philipp Lurz, MD, PhD
      • Sub-Investigator: Karl-Patrik Kresoja, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure with preserved ejection	Presence of heart failure with preserved ejection fraction according to the European Society of Cardiology 2016 criteria	At timepoint of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	At timepoint of inclusion
All-cause death	Patients will be screened on a yearly basis for the occurence of all-cause mortality	Yearly, after study enrollment up to ten years

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Heart failure; Heart failure with preserved ejection fraction; Adiposity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PREDICT-HFpEFv1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No