Right Ventricular Function and Pulmonary Hypertension in HFpEF (HFpEF-PHT)

Heart Center Leipzig - University Hospital

Status: Unknown

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Diagnostic Test: Invasive hemodynamics and myocardial biopsies

Study type: Observational

Funder types: Other

Identifiers

NCT05055180

HFpEF-PHT 1.1

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

45 participants in 3 patient groups

HFpEF with pulmonary hypertension

Description:

Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines

Treatment:

Diagnostic Test: Invasive hemodynamics and myocardial biopsies

HFpEF without pulmonary hypertension

Description:

Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines

Treatment:

Diagnostic Test: Invasive hemodynamics and myocardial biopsies

Patients without HFpEF

Description:

Patients without invasive evidence of HFpEF

Treatment:

Diagnostic Test: Invasive hemodynamics and myocardial biopsies