Acute Heart FailurePhase 2MEMONCT00449423
Metabolic Modulation as Treatment in Acute Heart Failure
A Phase 2 study testing acipimox in people with Acute Heart Failure, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- acipimox
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Oct 2007
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute heart failure
- NYHA class III - IV.
- ejection fraction <35
Who cannot join
- Age <18 år or >85 år,
- allergy
- renal failure
- recently developed brady- or tachy-arrythmias
- Serious infection
- Heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease
Show all 11Show fewer
- Recent Myocardial infarction (<6 Weeks)
- Pulmonary Wedge pressure >30 mm Hg
- diabetes mellitus treated with insulin
- peptic ulcer
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby Sygehus, Department of Cardiology
Aarhus, Aarhus, 8200
About this study
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure
Read the detailed description
Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.
- Conditions
- Acute Heart Failure
- Being tested
- acipimox
- Keywords
- Acute heart failure, Metabolic modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acipimoxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index
pulmonary Wedge Pressure
Ejection fraction
Secondary outcomes (4)
myocardial glucose- and Free Fatty Acid-extraction
cardiac output
Regional left ventricle function
outcome day 6 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Study completionOct 2007
Why it stopped: due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Mads Halbirk, dr., Principal investigator, Aarhus University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449423
- Sponsor's protocol ID
- 20060810
- Acronym
- MEMO
- Status last verified
- Oct 2007
- First submitted
- 19 Mar 2007
- Last updated
- 25 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Modulation as Treatment in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT00449423
- Acronym / sponsor ID
- MEMO / 20060810
- Conditions
- Acute Heart Failure
- Keywords
- Acute heart failure, Metabolic modulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow recruitment
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Mar 2007 (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.
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure
Detailed description
Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute heart failure
- NYHA class III - IV.
- ejection fraction <35
Key exclusion criteria (11 listed)
- Age <18 år or >85 år,
- allergy
- renal failure
- recently developed brady- or tachy-arrythmias
- Serious infection
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 |
|---|---|---|
| acipimox | Drug | – |
Primary outcome
Cardiac index
pulmonary Wedge Pressure
Ejection fraction
4 secondary outcomes
myocardial glucose- and Free Fatty Acid-extraction
cardiac output
Regional left ventricle function
outcome day 6 and 30
Results and safety
The study was stopped early (reason given: due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
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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.
Mads Halbirk, dr. principal investigator
Aarhus University Hospital, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acipimox in people with Acute Heart Failure, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 11 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 25 Oct 2007. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to slow recruitment). 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?
Cardiac index. The study lists 3 primary outcomes in all. 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 25 Oct 2007; AzTrials last refreshed its copy on 6 Nov 2026.