Right Ventricular Function and Pulmonary Hypertension in HFpEF

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Diagnostic Test: Invasive hemodynamics and myocardial biopsies

• Registration Number: NCT05055180
• Lead Sponsor: Heart Center Leipzig - University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFpEF with pulmonary hypertension	Invasive hemodynamics and myocardial biopsies	Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines
HFpEF without pulmonary hypertension	Invasive hemodynamics and myocardial biopsies	Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines
Patients without HFpEF	Invasive hemodynamics and myocardial biopsies	Patients without invasive evidence of HFpEF

Primary Outcome Measures

Name	Time	Method
Phosphorylation of structural myocardial proteins	Baseline	Assessed on myocardial biopsy specimen
Right ventricular systolic and diastolic function	Baseline	Assessed with pressure volume loops analysis
Biventricular myocardial fibrosis	Baseline	Assessed with histopathology

Secondary Outcome Measures

Name	Time	Method
Functional capacity	Baseline	6-Minute Walk Test / Spiroergometry
Myocardial fibrosis on cardiac magnetic resonance	Baseline

Trial Locations

Locations (1)

Heart Center Leipzig at Leipzig University; 🇩🇪 Leipzig, Saxony, Germany