Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
- Conditions
- Dyspnea
- Interventions
- Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
- Registration Number
- NCT04688905
- Lead Sponsor
- University of Leipzig
- 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- dyspnea NYHA II-III
- age 18-90 years
- left ventricular ejection fraction ≥ 50%
- ability to give informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dyspnea explained by heart failure with preserved ejection fraction Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion All patients fulfilling invasive criteria for heart failure with preserved ejection fraction Dyspnea not explained by heart failure with preserved ejection fraction 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
- Primary Outcome Measures
Name Time Method HFpEF-positive patients Within one day Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction
- Secondary Outcome Measures
Name Time Method Difference in E/E' (echocardiographic) Within two days E/E' (at rest and under exertion) in patients with approved and excluded HFpEF
H2FPEF score 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)
Difference in MRI parameters Within two days Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF
Difference in pulmonary artery pressure (right heart catheter) Within two days Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF
HFA-PEFF score 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.
Difference in DPVQ (echocardiographic) after one year 1 year Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year
Difference in E/E' (echocardiographic) after one year 1 year E/E' at rest in patients with approved and excluded HFpEF after one year
Difference in DPVQ (echocardiographic) Within two days Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF
Difference in GLS (echocardiographic) Within two days Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF
Difference in wedge pressure (right heart catheter) Within two days Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF
Difference in GLS (echocardiographic) after one year 1 year Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year
Trial Locations
- Locations (1)
Universitätsklinikum Leipzig
🇩🇪Leipzig, Saxony, Germany