Heart FailureNCT02105805
Weight Loss as Treatment in Heart Disease
A study testing Dietetic group sessions in people with Heart Failure, run by University of Copenhagen.
Trial summary
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects. All will receive dietetic advice according to randomization and according to the European Heart Association. 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?
- Dietetic group sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Aug 2011
- 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
- bmi >30
- heart failure, moderate to severe, new york heart association II og III
- stable disease
- age >18 years
- out-patients
- perform a six minutes walk test
- given consent
Who cannot join
- unstable disease
- insulin treated diabetes
- pregnancy or lactating
- unstable weight past 6 months (+- 10 kg)
- planned procedures in the time of intervention
About this study
Official title: Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.
All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
- Conditions
- Heart Failure
- Being tested
- Dietetic group sessions
- Keywords
- intention weight loss, heart failure, 6-minute walk test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietetic group sessionsBehavioural
Group sessions to improve dietary adherence
| Study group | Role | What they receive |
|---|---|---|
| low energy diet | Experimental | low energy diet treatment Receives: Behavioral: Dietetic group sessions |
| Nordic recommendation | Active comparator | Nordic recommendation, no restrictions on energy Receives: Behavioral: Dietetic group sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six minute walk test from baseline to week 16 (end of study)
Performance measure
Measured: weeks 0 and 16
Secondary outcomes (1)
Change in lipid status from baseline to week 16 (end of study).
Blood sample and analyses for lipids
Measured: weeks 0,1,2,4,6,8,10,12,14,16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
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 CopenhagenThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105805
- Sponsor's protocol ID
- GEN-01-clinnutr
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
- ClinicalTrials.gov ID
- NCT02105805
- Acronym / sponsor ID
- GEN-01-clinnutr
- Conditions
- Heart Failure
- Keywords
- intention weight loss, heart failure, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Apr 2014 (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.
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.
All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low energy diet | Experimental | Behavioral: Dietetic group sessionslow energy diet treatment |
| Nordic recommendation | Active comparator | Behavioral: Dietetic group sessionsNordic recommendation, no restrictions on energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- bmi >30
- heart failure, moderate to severe, new york heart association II og III
- stable disease
- age >18 years
- out-patients
Key exclusion criteria (5 listed)
- unstable disease
- insulin treated diabetes
- pregnancy or lactating
- unstable weight past 6 months (+- 10 kg)
- planned procedures in the time of intervention
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 |
|---|---|---|
| Dietetic group sessionsGroup sessions to improve dietary adherence | Behavioural | Nordic recommendation, low energy diet |
Primary outcome
Change in six minute walk test from baseline to week 16 (end of study)
Time frame: weeks 0 and 16
Performance measure
1 secondary outcome
Change in lipid status from baseline to week 16 (end of study).
Time frame: weeks 0,1,2,4,6,8,10,12,14,16
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 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietetic group sessions in people with Heart Failure, run by University of Copenhagen.
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 5 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Change in six minute walk test from baseline to week 16 (end of study) (time frame: weeks 0 and 16). 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 Apr 2014.