Right Ventricular Function and Pulmonary Hypertension in HFpEF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-12-30

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.

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Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF with pulmonary hypertension

Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines

Invasive hemodynamics and myocardial biopsies

Intervention Type DIAGNOSTIC_TEST

Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

HFpEF without pulmonary hypertension

Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines

Invasive hemodynamics and myocardial biopsies

Intervention Type DIAGNOSTIC_TEST

Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

Patients without HFpEF

Patients without invasive evidence of HFpEF

Invasive hemodynamics and myocardial biopsies

Intervention Type DIAGNOSTIC_TEST

Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

Interventions

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Invasive hemodynamics and myocardial biopsies

Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No