Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation (ANREP-EF)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Conductance catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility 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
Sites / Locations
- Universitätsklinikum Schleswig-Holstein
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HFPEF
HFREF
No HFPEF/HFREF
Arm Description
Patient with heart failure with preserved ejection fraction (HFPEF)
Patient with heart failure with reduced ejection fraction (HFREF)
Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index
Changes in contractility after handgrip exercise assessed by the peak power index
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"
Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"
Functional parameter: Changes in ejection fraction
Changes in ejection fraction after handgrip exercise assessed by echocardiography
Full Information
NCT ID
NCT02751853
First Posted
April 19, 2016
Last Updated
September 6, 2022
Sponsor
University of Luebeck
1. Study Identification
Unique Protocol Identification Number
NCT02751853
Brief Title
Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation
Acronym
ANREP-EF
Official Title
Effects of Acutely Elevated Afterload oN Left VentRicular Contractility and RElaxation in Heart Failure With Preserved and Reduced Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the heterogeneity in the first group.
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HFPEF
Arm Type
Experimental
Arm Description
Patient with heart failure with preserved ejection fraction (HFPEF)
Arm Title
HFREF
Arm Type
Experimental
Arm Description
Patient with heart failure with reduced ejection fraction (HFREF)
Arm Title
No HFPEF/HFREF
Arm Type
Active Comparator
Arm Description
Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)
Intervention Type
Device
Intervention Name(s)
Conductance catheter
Intervention Description
Continuous online measurements of left ventricular pressure and volume using conductance catheters
Primary Outcome Measure Information:
Title
Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship
Description
Changes in contractility after handgrip exercise assessed by the end-systolic pressure-volume relationship
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index
Description
Changes in contractility after handgrip exercise assessed by the peak power index
Time Frame
Day 1
Title
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"
Description
Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"
Time Frame
Day 1
Title
Functional parameter: Changes in ejection fraction
Description
Changes in ejection fraction after handgrip exercise assessed by echocardiography
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation
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