Heart FailureACMENCT00549614
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure
A study testing acipimox in people with 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 left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- acipimox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to May 2009
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EF<40 %
- IHD
- NYHA-class II-III.
Who cannot join
- pregnancy
- severe renal failure
- new brady- or tachyArrhythmia
- Severe stenotic valvular disease
- myocardial infarction within last 6 weeks
- insulin treated diabetes mellitus
Show all 9Show fewer
- peptic ulcer
- pregnancy or lactating women
- allergy towards tested medicine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aarhus Universityhospital, Skejby
Aarhus N, 8200
About this study
Official title: Effect of 4 Weeks Treatment With Acipimox on Left Ventricular Function, Work Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure
The primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure
- Conditions
- Heart Failure
- Being tested
- acipimox, placebo
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acipimoxDrug
capsule, 250 mg, 4 times daily for 28 days
placeboDrug
capsule, 250 mg, 4 times daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: acipimox |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection Fraction
Measured: 4 weeks
exercise capacity
Measured: 4 weeks
muscular metabolism
Measured: 4 weeks
Secondary outcomes (3)
regional left ventricular function
Measured: 4 weeks
insulin resistance
Measured: 4 weeks
full body metabolism
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionMay 2009
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Mads Halbirk, Principal investigator, B-research, Aarhus Universityhospital, skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549614
- Sponsor's protocol ID
- 20061218
- Acronym
- ACME
- Status last verified
- Oct 2009
- First submitted
- 25 Oct 2007
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Weeks Treatment With Acipimox on Left Ventricular Function, Work Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00549614
- Acronym / sponsor ID
- ACME / 20061218
- Conditions
- Heart Failure
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Oct 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 left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: acipimox |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- EF<40 %
- IHD
- NYHA-class II-III.
Key exclusion criteria (9 listed)
- pregnancy
- severe renal failure
- new brady- or tachyArrhythmia
- Severe stenotic valvular disease
- myocardial infarction within last 6 weeks
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 |
|---|---|---|
| acipimoxcapsule, 250 mg, 4 times daily for 28 days | Drug | 1 |
| placebocapsule, 250 mg, 4 times daily for 28 days | Drug | 2 |
Primary outcome
left ventricular ejection Fraction
Time frame: 4 weeks
exercise capacity
Time frame: 4 weeks
muscular metabolism
Time frame: 4 weeks
3 secondary outcomes
regional left ventricular function
Time frame: 4 weeks
insulin resistance
Time frame: 4 weeks
full body metabolism
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
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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 principal investigator
B-research, Aarhus Universityhospital, skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acipimox in people with 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 9 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: finished, as of the sponsor's last update on 7 Oct 2009. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
left ventricular ejection Fraction (time frame: 4 weeks). 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 7 Oct 2009.