Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00497003
Other study ID # KF 02-071/03
Secondary ID
Status Completed
Phase Phase 4
First received July 5, 2007
Last updated October 12, 2007
Start date February 2004
Est. completion date October 2007

Study information

Verified date July 2007
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Chronic heart failure

Exclusion Criteria:

- 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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Treatment with either metoprolol or carvedilol


Locations

Country Name City State
Denmark Department of Cardiology, University Hospital of Copenhagen, Bispebjerg Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Bispebjerg Hospital Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial function and insulin stimulated endothelial function 2 months
Secondary Insulin stimulated glucose uptake 2 months
See also
  Status Clinical Trial Phase
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Recruiting NCT02500329 - Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients Phase 4
Completed NCT01947790 - Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease Phase 4
Completed NCT01028599 - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients N/A
Completed NCT00575120 - Endothelial Function Assessed With BOLD-MRI N/A
Active, not recruiting NCT05451641 - Blood Flow Restriction Resistance Training Intervention on Vascular Function N/A
Completed NCT01713374 - Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System N/A
Completed NCT03651713 - Hyperglycemia, Exercise, and Endothelial Function N/A
Completed NCT00844714 - Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy N/A
Completed NCT00967252 - Impact of Chronic Statin Use During Surgery on Inflammation and Infection Rates N/A
Completed NCT01256957 - Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health N/A
Completed NCT00728221 - Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation Phase 2
Completed NCT00845013 - Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
Completed NCT00534651 - Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease Phase 4
Recruiting NCT04689477 - Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
Completed NCT01610401 - The Metformin-FMD Trial Phase 4
Completed NCT01829542 - Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals N/A
Terminated NCT00942643 - Endothelial Damage and Atherosclerosis in Obstructive Sleep Apnea N/A
Completed NCT05235958 - VascuFit: Exercise and Vascular Aging N/A
Not yet recruiting NCT06288828 - The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis N/A