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TerminatedNCT02751853ANREP-EFUpdated Sep 10, 2022

Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

An interventional study of Conductance catheter in Heart Failure, sponsored by University of Luebeck. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.

Sponsored by University of Luebeck · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Due to the heterogeneity in the first group.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

Aim of the study is to assess the effects of abruptly increased afterload on left ventricular contractility and relaxation in patients with heart failure with preserved ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients without HFPEF or HFREF.

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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 20 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

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Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical indication for left and right heart catheterization
  • HFPEF (Group 1) OR HFREF (Group 2) OR absent echocardiographic evidence of HFREF OR HFPEF(Group 3)

AND

  • Sinus rhythm during invasive measurements
  • Age ≥18 years
  • Negative pregnancy test in women with childbearing potential
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Acute coronary syndrome
  • Acute myocardial infarction \<6 months
  • Planned cardiac surgery or cardiovascular intervention within 6 months following inclusion
  • Valvular heart disease >2°
  • Severe comorbidities with limited life expectancy \<12 months
  • Precapillary pulmonary hypertension
  • Participation in another trial
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    HFPEF

    Patient with heart failure with preserved ejection fraction (HFPEF)

    Device: Conductance catheter

  • Experimental
    HFREF

    Patient with heart failure with reduced ejection fraction (HFREF)

    Device: Conductance catheter

  • Active comparator
    No HFPEF/HFREF

    Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)

    Device: Conductance catheter

Interventions

  • DeviceConductance catheter

    Continuous online measurements of left ventricular pressure and volume using conductance catheters

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What researchers measure

Primary outcomes

  1. Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship

    Changes in contractility after handgrip exercise assessed by the end-systolic pressure-volume relationship

    Time frame: Day 1

Secondary outcomes

  1. Hemodynamic parameter 2: Changes in contractility assessed by the peak power index

    Changes in contractility after handgrip exercise assessed by the peak power index

    Time frame: Day 1

  2. Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"

    Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"

    Time frame: Day 1

  3. Functional parameter: Changes in ejection fraction

    Changes in ejection fraction after handgrip exercise assessed by echocardiography

    Time frame: Day 1

07

Study locations

1 site
  • Universitätsklinikum Schleswig-Holstein
    Lübeck, Schleswig-Holstein 23538, Germany
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02751853
Lead sponsor
University of Luebeck
Responsible party
Holger Thiele (Director, Department of Cardiology, Angiology, and Intensive Care Medicine, University Heart Center Luebeck, University of Luebeck) — Principal investigator
First posted
Apr 26, 2016
Start date
Dec 2016
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Sep 10, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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