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Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation (ANREP-EF)

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ClinicalTrials.gov Identifier: NCT02751853
Recruitment Status : Not yet recruiting
First Posted : April 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Luebeck

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Conductance catheter Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Acutely Elevated Afterload oN Left VentRicular Contractility and RElaxation in Heart Failure With Preserved and Reduced Ejection Fraction
Study Start Date : December 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: HFPEF
Patient with heart failure with preserved ejection fraction (HFPEF)
Device: Conductance catheter
Continuous online measurements of left ventricular pressure and volume using conductance catheters

Experimental: HFREF
Patient with heart failure with reduced ejection fraction (HFREF)
Device: Conductance catheter
Continuous online measurements of left ventricular pressure and volume using conductance catheters

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




Primary Outcome Measures :
  1. Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship [ Time Frame: Day 1 ]
    Changes in contractility after handgrip exercise assessed by the end-systolic pressure-volume relationship


Secondary Outcome Measures :
  1. Hemodynamic parameter 2: Changes in contractility assessed by the peak power index [ Time Frame: Day 1 ]
    Changes in contractility after handgrip exercise assessed by the peak power index

  2. Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau" [ Time Frame: Day 1 ]
    Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"

  3. Functional parameter: Changes in ejection fraction [ Time Frame: Day 1 ]
    Changes in ejection fraction after handgrip exercise assessed by echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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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Responsible Party: Holger Thiele, Director, Department of Cardiology, Angiology, and Intensive Care Medicine, University Heart Center Luebeck, University of Luebeck
ClinicalTrials.gov Identifier: NCT02751853     History of Changes
Other Study ID Numbers: 16-011
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases