NCT05055180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

September 14, 2021

Last Update Submit

September 14, 2021

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Functional capacity

    Baseline

  • Myocardial fibrosis on cardiac magnetic resonance

    Baseline

Study Arms (3)

HFpEF with pulmonary hypertension

Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines

Diagnostic Test: Invasive hemodynamics and myocardial biopsies

HFpEF without pulmonary hypertension

Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines

Diagnostic Test: Invasive hemodynamics and myocardial biopsies

Patients without HFpEF

Patients without invasive evidence of HFpEF

Diagnostic Test: Invasive hemodynamics and myocardial biopsies

Interventions

Invasive hemodynamics and myocardial biopsiesDIAGNOSTIC_TEST

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

HFpEF with pulmonary hypertensionHFpEF without pulmonary hypertensionPatients without HFpEF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient general cardiology clinic

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center Leipzig at Leipzig University

Leipzig, Saxony, 04289, Germany

RECRUITING

Related 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 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.

    PMID: 29449367RESULT

  • 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.

    PMID: 31053957RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biventricular myocardial tissue samples. Peripheral blood samples.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 24, 2021

Study Start

October 1, 2018

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

DE(1)