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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Diagnostic test: Invasive hemodynamics and myocardial biopsies

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • Heart Center Leipzig at Leipzig University
      • Contact: Philipp Lurz, MD, PhD; Phone Number: +49341865252022; Email: Philipp.Lurz@medizin.uni-leipzig.de
      • Principal Investigator: Philipp Lurz, MD, PhD
      • Sub-Investigator: Karl-Patrik Kresoja, MD
      • Contact: Karl-Philpp Rommel, MD; Phone Number: +49341865252529; Email: Karl-Philip.Rommel@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatient general cardiology clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HFpEF with pulmonary hypertension; Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines	Diagnostic test: Invasive hemodynamics and myocardial biopsies; 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	Diagnostic test: Invasive hemodynamics and myocardial biopsies; Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies
Patients without HFpEF; Patients without invasive evidence of HFpEF	Diagnostic test: Invasive hemodynamics and myocardial biopsies; Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Collaborators: University Hospital Muenster; University Hospital Tuebingen

Publications and helpful links

General Publications

• 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 Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.
• von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke 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 Jan;109(1):54-66. doi: 10.1007/s00392-019-01484-0. Epub 2019 May 3.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HFpEF-PHT 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No