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Prediction of the Development of Heart Failure With Preserved Ejection Fraction

NCT04894968 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2022-03-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2022-05-31
Completion
2022-11-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894968 on ClinicalTrials.gov