Phase 3
N=114
Irbesartan and Atenolol in Hypertensive Heart Disease
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00389168 ↗Enrolled (actual)
114
Serious AEs
8.8%
Results posted
May 2015
Primary outcome: Primary: Changes in Left Ventricular Mass Index — -1; -9; -6; -14 g/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Irbesartan (Drug); Atenolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Apr 1997
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Left Ventricular Mass Index |
-1; -9; -6; -14; -14; -26 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
5; 5 | — |
| SECONDARY Left Ventricular Diastolic Function Assessed by the E/A Ratio |
0.18; 0.10; 0.16; 0.04; 0.13; 0.10 | — |
| SECONDARY Blood Pressure |
-16.3; -18.8 | — |
| SECONDARY Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System |
-1.0; 3.0; -0.8; 3.3; -0.2; 10.0 | — |
| SECONDARY Effects on Carotid Artery Wall Thickness |
0.03; -0.01 | — |
Summary
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 weeks. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00389168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.