Prediction of the Development of Heart Failure With Preserved Ejection Fraction

NCT04894968 | Unknown

• 1 other identifier: PREDICT-HFpEFv1
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure with preserved ejection fraction; Heart failure; Adiposity; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Occurence of major adverse cardiovascular events

  24-months after study inclusion

• Changes in vascular status

  At timepoint of inclusion

• Changes in organ function

  At timepoint of inclusion

• All-cause death

  Yearly, after study enrollment up to ten years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• 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
• No troponine elevation but coronary intervention
• 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

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (1)

Heart Center Leipzig at Leipzig University

Leipzig, Saxony, 04289, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 27081022 BACKGROUND

• 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.

  PMID: 29449367 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Philipp Lurz, MD, PhD

CONTACT

0341865252022; philipp.lurz@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: December 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

DE (1)