Study Stopped
Due to the heterogeneity in the first group.
Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation
ANREP-EF
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Dec 2016
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedSeptember 10, 2022
September 1, 2022
5.8 years
April 19, 2016
September 6, 2022
Conditions
Outcome Measures
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
Day 1
Secondary Outcomes (3)
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index
Day 1
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"
Day 1
Functional parameter: Changes in ejection fraction
Day 1
Study Arms (3)
HFPEF
EXPERIMENTALPatient with heart failure with preserved ejection fraction (HFPEF)
HFREF
EXPERIMENTALPatient with heart failure with reduced ejection fraction (HFREF)
No HFPEF/HFREF
ACTIVE COMPARATORPatient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)
Interventions
Continuous online measurements of left ventricular pressure and volume using conductance catheters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acute coronary syndrome
- Acute myocardial infarction \<6 months
- Valvular heart disease \>2°
- Severe comorbidities with limited life expectancy \<12 months
- Precapillary pulmonary hypertension
- Participation in another trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Cardiology, Angiology, and Intensive Care Medicine, University Heart Center Luebeck
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 26, 2016
Study Start
December 1, 2016
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
September 10, 2022
Record last verified: 2022-09