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NCT Number: NCT04688905

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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)

Primary outcomes

  1. HFpEF-positive patients

    Time frame: Within one day

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

Secondary outcomes

  1. H2FPEF score

    Time frame: Within two days

    Difference in H2FPEF score in patients with approved and excluded HFpEF (BMI > 30 kg/m²: 2 points, 2 or more antihypertensive medicines: 1 point, atrial fibrillation: 3 points, pulmonary hypertension: 1 point, age > 60 years: 1 point, E/E' > 9: 1 point. Sum: 0-9 points with rising probability of HFpEF with increasing score)

  2. HFA-PEFF score

    Time frame: Within two days

    Difference in HFA-PEFF score in patients with approved and excluded HFpEF (0-2 points regarding functional, morpholigical and biomarker parameters. Sum: 0-6 points; 0-1 points:exclusion of HFpEF, 2-5 points: further diagnostic (stress test or invasive) required, 5-6 points: HFpEF diagnosed.

  3. Difference in DPVQ (echocardiographic)

    Time frame: Within two days

    Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF

  4. Difference in E/E' (echocardiographic)

    Time frame: Within two days

    E/E' (at rest and under exertion) in patients with approved and excluded HFpEF

  5. Difference in GLS (echocardiographic)

    Time frame: Within two days

    Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF

  6. Difference in MRI parameters

    Time frame: Within two days

    Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF

  7. Difference in pulmonary artery pressure (right heart catheter)

    Time frame: Within two days

    Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF

  8. Difference in wedge pressure (right heart catheter)

    Time frame: Within two days

    Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF

  9. Difference in DPVQ (echocardiographic) after one year

    Time frame: 1 year

    Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year

  10. Difference in E/E' (echocardiographic) after one year

    Time frame: 1 year

    E/E' at rest in patients with approved and excluded HFpEF after one year

  11. Difference in GLS (echocardiographic) after one year

    Time frame: 1 year

    Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Dec 30, 2020
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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