Endothelial FunctionPhase 4NCT00497003
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
A Phase 4 study testing Treatment with either metoprolol or carvedilol in people with Endothelial Function and Beta Blocker, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure. Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial function. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function, Beta Blocker
- What is being tested?
- Treatment with either metoprolol or carvedilol
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2004to Oct 2007
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Chronic heart failure
Who cannot join
- For patients with type 2 diabetes:
- Vascular complications.
- For patients with chronic heart failure:
- Severe uncontrolled heart failure.
- Untreated severe hypertension, hypotension.
- Bradycardia.
- Known intolerance to beta blocker treatment.
- Pregnancy,
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, University Hospital of Copenhagen, Bispebjerg
Copenhagen, 2400
About this study
The aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure.
Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial function.
2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated endothelial function.
The study is conducted as an open parallel group study. Endothelial function and insulin stimulated endothelial function was evaluated before and after a two months treatment period with either of the two beta blockers.
Read the detailed description
Endothelial function is deteriorated in patients with type 2 diabetes and in patients with chronic heart failure. Treatment with carvedilol improves survival in patients with chronic heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol also decreases the number of patients with new onset diabetes among patients with chronic heart failure. The mechanism behind these findings has not been fully understood.
The purpose of this study is to investigate if carvedilol compared to metoprolol has a favourable effect on endothelial function and insulin stimulated endothelial function, in groups of patients with either diabetes or chronic heart failure.
- Conditions
- Endothelial Function, Beta Blocker
- Being tested
- Treatment with either metoprolol or carvedilol
- Keywords
- Endothelial function, Beta blocker, Type 2 diabetes, Chronic heart failure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with either metoprolol or carvedilolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function and insulin stimulated endothelial function
Measured: 2 months
Secondary outcomes (1)
Insulin stimulated glucose uptake
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startFeb 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endothelial FunctionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Investigators
- Christian Torp-Pedersen, MD, DSc, Principal investigator, Department of Cardiology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497003
- Sponsor's protocol ID
- KF 02-071/03
- Status last verified
- Jul 2007
- First submitted
- 5 Jul 2007
- Last updated
- 15 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Falskov B, Hermann TS, Raunso J, Christiansen B, Rask-Madsen C, Major-Pedersen A, Kober L, Torp-Pedersen C, Dominguez H. Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure--a randomized study. Cardiovasc Diabetol. 2011 Oct 15;10:91. doi: 10.1186/1475-2840-10-91.
PubMed 21999413Kveiborg B, Hermann TS, Major-Pedersen A, Christiansen B, Rask-Madsen C, Raunso J, Kober L, Torp-Pedersen C, Dominguez H. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study. Cardiovasc Diabetol. 2010 May 25;9:21. doi: 10.1186/1475-2840-9-21.
PubMed 20500877
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00497003
- Acronym / sponsor ID
- KF 02-071/03
- Conditions
- Endothelial Function, Beta Blocker
- Keywords
- Endothelial function, Beta blocker, Type 2 diabetes, Chronic heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Feb 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Jul 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 aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure.
Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial function.
2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated endothelial function.
The study is conducted as an open parallel group study. Endothelial function and insulin stimulated endothelial function was evaluated before and after a two months treatment period with either of the two beta blockers.
Detailed description
Endothelial function is deteriorated in patients with type 2 diabetes and in patients with chronic heart failure. Treatment with carvedilol improves survival in patients with chronic heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol also decreases the number of patients with new onset diabetes among patients with chronic heart failure. The mechanism behind these findings has not been fully understood.
The purpose of this study is to investigate if carvedilol compared to metoprolol has a favourable effect on endothelial function and insulin stimulated endothelial function, in groups of patients with either diabetes or chronic heart failure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Chronic heart failure
Key exclusion criteria (8 listed)
- For patients with type 2 diabetes:
- For patients with chronic heart failure:
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 |
|---|---|---|
| Treatment with either metoprolol or carvedilol | Drug | – |
Primary outcome
Endothelial function and insulin stimulated endothelial function
Time frame: 2 months
1 secondary outcome
Insulin stimulated glucose uptake
Time frame: 2 months
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 15 Oct 2007.
- Derived from this study: PubMed 21999413Falskov B, Hermann TS, Raunso J, Christiansen B, Rask-Madsen C, Major-Pedersen A, Kober L, Torp-Pedersen C, Dominguez H. Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure--a randomized study. Cardiovasc Diabetol. 2011 Oct 15;10:91. doi: 10.1186/1475-2840-10-91.
- Derived from this study: PubMed 20500877Kveiborg B, Hermann TS, Major-Pedersen A, Christiansen B, Rask-Madsen C, Raunso J, Kober L, Torp-Pedersen C, Dominguez H. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study. Cardiovasc Diabetol. 2010 May 25;9:21. doi: 10.1186/1475-2840-9-21.
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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.
Christian Torp-Pedersen, MD, DSc principal investigator
Department of Cardiology, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with either metoprolol or carvedilol in people with Endothelial Function and Beta Blocker, run by Bispebjerg Hospital 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 2 inclusion and 8 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 15 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Endothelial function and insulin stimulated endothelial function (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00497003, which also lists 2 linked publications.
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 15 Oct 2007.