Chronic Heart FailureNCT02013739
Description of Insulin Resistance in Patients With Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Hasselt University at 1 site in Belgium.
Trial summary
The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with chronic heart failure
Who may be able to join
- diagnosis of chronic heart failure for at least 6 months,
- clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,
Who cannot join
- glucose lowering medical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of Insulin Resistance and Explanatory Variables in Patients With Chronic Heart Failure
The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function.
It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.
- Conditions
- Chronic Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic heart failure | other | |
| Healthy volontiers | other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
glucose and insulin concentration measurements in blood during oral glucose tolerance test
Measured: day1
Secondary outcomes (5)
HbA1c, blood lipids, BNP
Measured: day 1
Muscle strength: maximal strength tested on a isokinetic dynamometer
Measured: Day 1
Body composition: dual energy x-ray absorptiometry
Measured: Day 1
cardiac function: echocardiography, retrospective from hospital files
Measured: retrospective
Health-related quality of life: MLHFQ and Eq5d
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 posted17 Dec 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Bert Op 't Eijnde, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013739
- Sponsor's protocol ID
- 11.78/cardio11.13
- Status last verified
- Dec 2013
- First submitted
- 8 Dec 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Insulin Resistance and Explanatory Variables in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02013739
- Acronym / sponsor ID
- 11.78/cardio11.13
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Dec 2013 (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 purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function.
It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic heart failure | – | –other |
| Healthy volontiers | – | –other |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with chronic heart failure
Key inclusion criteria (2 listed)
- diagnosis of chronic heart failure for at least 6 months,
- clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,
Key exclusion criteria (1 listed)
- glucose lowering medical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose tolerance
Time frame: day1
glucose and insulin concentration measurements in blood during oral glucose tolerance test
5 secondary outcomes
HbA1c, blood lipids, BNP
Time frame: day 1
Muscle strength: maximal strength tested on a isokinetic dynamometer
Time frame: Day 1
Body composition: dual energy x-ray absorptiometry
Time frame: Day 1
cardiac function: echocardiography, retrospective from hospital files
Time frame: retrospective
Health-related quality of life: MLHFQ and Eq5d
Time frame: Day 1
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 17 Dec 2013.
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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.
Bert Op 't Eijnde, prof. dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Hasselt University at 1 site in Belgium.
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 2 inclusion and 1 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 17 Dec 2013. 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 Belgium. 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 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?
Glucose tolerance (time frame: day1). 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 17 Dec 2013.