Heart FailureANREP-EFNCT02751853
Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation
A study testing Conductance catheter in people with Heart Failure, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Conductance catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Effects of Acutely Elevated Afterload oN Left VentRicular Contractility and RElaxation in Heart Failure With Preserved and Reduced Ejection Fraction
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.
- Conditions
- Heart Failure
- Being tested
- Conductance catheter
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conductance catheterDevice
Continuous online measurements of left ventricular pressure and volume using conductance catheters
| Study group | Role | What they receive |
|---|---|---|
| HFPEF | Experimental | Patient with heart failure with preserved ejection fraction (HFPEF) Receives: Device: Conductance catheter |
| HFREF | Experimental | Patient with heart failure with reduced ejection fraction (HFREF) Receives: Device: Conductance catheter |
| No HFPEF/HFREF | Active comparator | Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF) Receives: Device: Conductance catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (3)
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index
Changes in contractility after handgrip exercise assessed by the peak power index
Measured: Day 1
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"
Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"
Measured: Day 1
Functional parameter: Changes in ejection fraction
Changes in ejection fraction after handgrip exercise assessed by echocardiography
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startDec 2016
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Due to the heterogeneity in the first group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Thiele, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751853
- Sponsor's protocol ID
- 16-011
- Acronym
- ANREP-EF
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2016
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acutely Elevated Afterload oN Left VentRicular Contractility and RElaxation in Heart Failure With Preserved and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT02751853
- Acronym / sponsor ID
- ANREP-EF / 16-011
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the heterogeneity in the first group.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFPEF | Experimental | Device: Conductance catheterPatient with heart failure with preserved ejection fraction (HFPEF) |
| HFREF | Experimental | Device: Conductance catheterPatient with heart failure with reduced ejection fraction (HFREF) |
| No HFPEF/HFREF | Active comparator | Device: Conductance catheterPatient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conductance catheterContinuous online measurements of left ventricular pressure and volume using conductance catheters | Device | HFPEF, HFREF, No HFPEF/HFREF |
Primary outcome
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
3 secondary outcomes
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index
Time frame: Day 1
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"
Time frame: Day 1
Functional parameter: Changes in ejection fraction
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Due to the heterogeneity in the first group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conductance catheter in people with Heart Failure, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the heterogeneity in the first group.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.