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NCT Number: NCT00389168

Irbesartan and Atenolol in Hypertensive Heart Disease

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.

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Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory

Stockholm, SE-182 88, Sweden

About this study

We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

Titrated to 300 mg od, 48 weeks.

Other names: Aprovel

Atenolol

Drug

Titrated to 100 mg od, 48 weeks.

Other names: Tenormin

Primary outcomes

  1. Changes in Left Ventricular Mass Index

    Time frame: Baseline and 48 weeks

    Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).

Secondary outcomes

  1. Number of Participants With Serious Adverse Events

    Time frame: Treatment period was baseline to 48 weeks

    Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.

  2. Left Ventricular Diastolic Function Assessed by the E/A Ratio

    Time frame: Baseline to 48 weeks

    Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.

  3. Blood Pressure

    Time frame: Baseline to 48 weeks

    Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks

  4. Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System

    Time frame: Baseline to 48 weeks

    Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.

  5. Effects on Carotid Artery Wall Thickness

    Time frame: Baseline to 48 weeks

    Changes in common carotid artery intima-media thickness, assessed by ultrasonography.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Bristol-Myers Squibb
  • Sanofi
  • Swedish Heart Lung Foundation

Registry information

Official study title

Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy

Acronym: SILVHIA

Important dates

Study start
1995
Primary completion
1997
Study completion
1997
First posted
Oct 18, 2006
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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