Right Ventricular Function and Pulmonary Hypertension in HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

— HFpEF-PHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055180
• Other study ID #: HFpEF-PHT 1.1
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2021
• Source: Heart Center Leipzig - University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Diagnostic Test:
• Invasive hemodynamics and myocardial biopsies
Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

Locations

Country	Name	City	State
Germany	Heart Center Leipzig at Leipzig University	Leipzig	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital	University Hospital Muenster, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ej — View Citation

von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuß G, Lücke C, Gutberlet M, Thiele H, Schuster A, Lurz P. Right atrial-right ventricular coupling in heart failure with preserved ejection fraction. Clin Res Cardiol. 2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular systolic and diastolic function	Assessed with pressure volume loops analysis	Baseline
Primary	Biventricular myocardial fibrosis	Assessed with histopathology	Baseline
Primary	Phosphorylation of structural myocardial proteins	Assessed on myocardial biopsy specimen	Baseline
Secondary	Functional capacity	6-Minute Walk Test / Spiroergometry	Baseline
Secondary	Myocardial fibrosis on cardiac magnetic resonance		Baseline