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

NCT ID: NCT04688905

Last Updated: 2025-11-19

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-09

Study Completion Date

2026-08-30

Brief Summary

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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

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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 unexplained dyspnea NYHA II-III in order to identify patients with a heart failure with preserved ejection fraction (HFpEF). The results will be compared to previously reported diagnostic scores such as the H2FPEF and the HFA-PEFF score.

Conditions

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Dyspnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cardiac MRI at rest Echocardiography at rest and with exercise Spiroergometry 6 minute walking distance Right heart catherization at rest and with exercise Coronary angiography (if not performed within the last year)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Rolf Wachter

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

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.

Reference Type RESULT
PMID: 41233022 (View on PubMed)

Other Identifiers

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283/20

Identifier Type: -

Identifier Source: org_study_id

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