Right Ventricular Function and Pulmonary Hypertension in HFpEF

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05055180

Acronym

HFpEF-PHT

Enrollment

Registered

2021-09-24

Start date

2018-10-01

Completion date

2021-12-30

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

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.

Interventions

DIAGNOSTIC_TESTInvasive hemodynamics and myocardial biopsies

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Functional capacity	Baseline	6-Minute Walk Test / Spiroergometry
Myocardial fibrosis on cardiac magnetic resonance	Baseline	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026