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

NCT04688905 | Active Not Recruiting

• 1 other identifier: 283/20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• HFpEF-positive patients

  Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction

  Within one day

Secondary Outcomes (11)

• H2FPEF score

  Within two days

• HFA-PEFF score

  Within two days

• Difference in DPVQ (echocardiographic)

  Within two days

• Difference in E/E' (echocardiographic)

  Within two days

• Difference in GLS (echocardiographic)

  Within two days

Study Arms (2)

Dyspnea explained by heart failure with preserved ejection fraction

All patients fulfilling invasive criteria for heart failure with preserved ejection fraction

Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion

Dyspnea not explained by heart failure with preserved ejection fraction

All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction

Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion

Interventions

Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion 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.

Also known as: 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)

Dyspnea explained by heart failure with preserved ejection fraction; Dyspnea not explained by heart failure with preserved ejection fraction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unexplained dyspnea NYHA II-III

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

• 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.

  PMID: 41233022 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Approximately 40 ml of blood will be drawn for the conduction of hemogram, sodium, potassium, creatine, eGFR, urea, coagulation, TSH, CK, high-sensitivity troponin T, NT-proBNP, HbA1c, lipids, iron status as well as biobanking (at -80°C) for 15 years.

MeSH Terms

Conditions

Dyspnea

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 30, 2020
• Study Start: September 9, 2020
• Primary Completion: August 4, 2023
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

DE (1)