Prediction of the Development of Heart Failure With Preserved Ejection Fraction

NCT ID: NCT04894968

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-11-30

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heart Center Leipzig at Leipzig University

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Philipp Lurz, MD, PhD

Role: CONTACT

philipp.lurz@medizin.uni-leipzig.de

0341865252022

Facility Contacts

Philipp Lurz, MD, PhD

Role: primary

Philipp.Lurz@medizin.uni-leipzig.de

+49341865252022

Maximilian von Roeder, MD

Role: backup

maximilian.vonroeder@medizin.uni-leipzig.de

+49341865252517

References

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.

Reference Type: BACKGROUND

PMID: 27081022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29449367 (View on PubMed)

Other Identifiers

PREDICT-HFpEFv1

Identifier Type: -

Identifier Source: org_study_id