Status:

ACTIVE_NOT_RECRUITING

Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)

Lead Sponsor:

University of Leipzig

Conditions:

Dyspnea

Eligibility:

All Genders

18-90 years

Brief Summary

Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools

Detailed Description

Multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with u...

Eligibility Criteria

Inclusion

  • dyspnea NYHA II-III
  • age 18-90 years
  • left ventricular ejection fraction ≥ 50%
  • ability to give informed consent

Exclusion

  • unstable cardiac disease with acute decompensation
  • documented former LVEF ≤ 40%
  • heart valve disease with medium or high grade insufficiency or stenosis
  • coronary heart disease with hemodynamically relevant coronary stenosis
  • specific cardiomyopathia
  • acute or chronic cardiac inflammation (myocarditis, pericarditis)
  • former heart transplantation
  • relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea
  • FEV1/VC \< 70%
  • hemoglobin \< 5 mmol/l
  • pregnant or nursing women
  • contraindication for one of the diagnostic tests

Key Trial Info

Start Date :

September 9 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 30 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04688905

Start Date

September 9 2020

End Date

August 30 2026

Last Update

November 19 2025

Active Locations (1)

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Universitätsklinikum Leipzig

Leipzig, Saxony, Germany, 04103