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Irbesartan and Atenolol in Hypertensive Heart Disease

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Swedish Heart Lung Foundation
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00389168
First received: October 17, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 17, 2006
October 17, 2006
April 1995
Not Provided
Safety and tolerability of irbesartan compared to atenolol
Same as current
No Changes Posted
  • Compare changes in left ventricular mass
  • Evaluate changes in diastolic function
  • Compare changes in blood pressure
  • Examine the relationship between changes in left ventricular mass and sympathetic influence, and influence of the renin-angiotensin-aldosterone system
  • Compare the effects on carotid artery wall thickness
Same as current
Not Provided
Not Provided
 
Irbesartan and Atenolol in Hypertensive Heart Disease
Randomized, Double-Blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy

The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.

This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 w. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.

We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h AMP monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Irbesartan vs atenolol
Not Provided
Malmqvist K, Kahan T, Edner M, Held C, Hagg A, Lind L, Muller-Brunotte R, Nystrom F, Ohman KP, Osbakken MD, Ostergern J. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens. 2001 Jun;19(6):1167-76.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
April 1997
Not Provided

Inclusion Criteria:

  • At least 18 ys old
  • Male or female with no child bearing potential
  • Seated blood pressure diastolic 90-115 mm Hg
  • Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
  • Informed consent

Exclusion Criteria:

  • Coronary artery disease, heart failure or other significant cardiac disorder
  • Cerebrovascular accident within the past 6 months
  • A seated systolic blood pressure above 200 mm Hg
  • Significant renal disease, collagen or vascular disease, or gastrointestinal condition
  • Significant allergy or intolerance to study drug
  • Alcohol or drug abuse
  • Uncontrolled diabetes mellitus
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00389168
CV131-052
Not Provided
Not Provided
Karolinska Institutet
  • Bristol-Myers Squibb
  • Sanofi
  • Swedish Heart Lung Foundation
Study Chair: Thomas Kahan, MD, PhD Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden
Karolinska Institutet
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP