Right Ventricular Function and Pulmonary Hypertension in HFpEF

Study Overview
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Brief Summary
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In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.

Official Title
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Afterload Dependence of Right Ventricular Myocardial Remodeling and Intrinsic Right Ventricular Myocardial Function in Heart Failure With Preserved Ejection Fraction

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Diagnostic Test: Invasive hemodynamics and myocardial biopsies


Participation Criteria
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Eligibility Criteria
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HFpEF Inclusion Criteria: Clinical signs of heart failure Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%) Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide > 125ng/l Elevated LV end-diastolic pressure at rest (>15mmHg) or during exertion (>=25mmHg) No Heart Failure Inclusion Criteria: No signs of heart failure Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%) Normal LV end-diastolic pressure at rest (=<15mmHg) and during exertion (<25mmHg) Exclusion Criteria: Significant coronary artery stenosis at time of catheterization Acute coronary syndrome or cerebral insult within 1 month of examination more than moderate valvular diseases pregnancy contraindication to cardiac magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| HFpEF with pulmonary hypertension<br>Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines | Diagnostic Test: Invasive hemodynamics and myocardial biopsies<br>* Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies<br>|
| HFpEF without pulmonary hypertension<br>Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines | Diagnostic Test: Invasive hemodynamics and myocardial biopsies<br>* Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies<br>|
| Patients without HFpEF<br>Patients without invasive evidence of HFpEF | Diagnostic Test: Invasive hemodynamics and myocardial biopsies<br>* Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular systolic and diastolic function | Assessed with pressure volume loops analysis | Baseline | 
| Biventricular myocardial fibrosis | Assessed with histopathology | Baseline | 
| Phosphorylation of structural myocardial proteins | Assessed on myocardial biopsy specimen | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | 6-Minute Walk Test / Spiroergometry | Baseline | 
| Myocardial fibrosis on cardiac magnetic resonance |  | Baseline |