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

Study Overview
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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.

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

Conditions
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Dyspnea

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dyspnea explained by heart failure with preserved ejection fraction<br>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<br>* 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.<br>* Other names: Coronary angiography (if not performed within the last year);|
| Dyspnea not explained by heart failure with preserved ejection fraction<br>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<br>* 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.<br>* Other names: Coronary angiography (if not performed within the last year);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HFpEF-positive patients | Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction | Within one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | Within two days | 
| Difference in DPVQ (echocardiographic) | Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | 
| Difference in E/E' (echocardiographic) | E/E' (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | 
| Difference in GLS (echocardiographic) | Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | 
| Difference in MRI parameters | Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF | 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 | Within two days | 
| Difference in wedge pressure (right heart catheter) | Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF | 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 | 1 year | 
| Difference in E/E' (echocardiographic) after one year | E/E' at rest in patients with approved and excluded HFpEF after one year | 1 year | 
| Difference in GLS (echocardiographic) after one year | Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year | 1 year |