An observational study in Dyspnea, sponsored by University of Leipzig. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by University of Leipzig · Observational
Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools
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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 30 is below the median of 122 across 204 observational studies indexed under Dyspnea.
Browse Dyspnea studies →University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
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Patients with unexplained dyspnea NYHA II-III
Exclusion Criteria:
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
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
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)
HFpEF-positive patients
Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction
Time frame: Within one day
H2FPEF score
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)
Time frame: Within two days
HFA-PEFF score
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.
Time frame: Within two days
Difference in DPVQ (echocardiographic)
Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in E/E' (echocardiographic)
E/E' (at rest and under exertion) in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in GLS (echocardiographic)
Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in MRI parameters
Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in pulmonary artery pressure (right heart catheter)
Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in wedge pressure (right heart catheter)
Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF
Time frame: Within two days
Difference in DPVQ (echocardiographic) after one year
Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year
Time frame: 1 year
Difference in E/E' (echocardiographic) after one year
E/E' at rest in patients with approved and excluded HFpEF after one year
Time frame: 1 year
Difference in GLS (echocardiographic) after one year
Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year
Time frame: 1 year
Plan to share: Undecided — Available upon reasonable scientific request.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of Leipzig