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| Sponsor: | Bispebjerg Hospital |
|---|---|
| Collaborator: |
Danish Heart Foundation |
| Information provided by: | Bispebjerg Hospital |
| ClinicalTrials.gov Identifier: | NCT00497003 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endothelial Function Beta Blocker |
Drug: Treatment with either metoprolol or carvedilol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Enrollment: | 50 |
| Study Start Date: | February 2004 |
| Study Completion Date: | October 2007 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
For patients with type 2 diabetes:
* Vascular complications.
For patients with chronic heart failure:
Contacts and Locations| Denmark | |
| Department of Cardiology, University Hospital of Copenhagen, Bispebjerg | |
| Copenhagen, Denmark, 2400 | |
| Principal Investigator: | Christian Torp-Pedersen, MD, DSc | Department of Cardiology, Bispebjerg Hospital |
More Information
| Study ID Numbers: | KF 02-071/03 |
| Study First Received: | July 5, 2007 |
| Last Updated: | October 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00497003 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee |
|
Endothelial function Beta blocker Type 2 diabetes Chronic heart failure |
|
Vasodilator Agents Sympatholytics Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents |
Metoprolol Pharmacologic Actions Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Carvedilol |
