Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
NCT ID: NCT04688905
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
30 participants
OBSERVATIONAL
2020-09-09
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dyspnea explained by heart failure with preserved ejection fraction
All patients fulfilling invasive criteria for heart failure with preserved ejection fraction
Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.
Dyspnea not explained by heart failure with preserved ejection fraction
All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction
Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.
Interventions
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Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-90 years
* left ventricular ejection fraction ≥ 50%
* ability to give informed consent
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Rolf Wachter
Professor
Locations
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Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Countries
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References
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Gessner R, Hubner AC, Stobe S, Rudolph UM, Unger L, Schmeisser A, Steendijk P, Uhe T, Stegmann T, Lavall D, Hagendorff A, Laufs U, Wachter R. Diagnosing HFpEF in Patients With Unexplained Dyspnea by Using Invasive Left Ventricular Pressure-Volume Loops. J Card Fail. 2025 Nov;31(11):1661-1671. doi: 10.1016/j.cardfail.2025.09.010.
Other Identifiers
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283/20
Identifier Type: -
Identifier Source: org_study_id
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