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Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Phase 4
Completed
Conditions
Hypertension
Left Ventricular Hypertrophy
Registration Number
NCT00139555
Lead Sponsor
Novartis
Brief Summary

Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
125
Inclusion Criteria
  • Males or female patients ≥ 55 years of age
  • LVH as confirmed by echocardiogram
  • Patients with high risk hypertension, currently treated or already taking antihypertensive medication
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Exclusion Criteria
  • Renal artery stenosis
  • Symptomatic heart failure or known ejection fraction < 40%
  • Myocardial infarction or stroke within 6 months
  • Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
  • Pregnant or lactating females
  • Cancer within the last 5 years
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in left ventricular mass index after 52 weeks
Secondary Outcome Measures
NameTimeMethod
Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
Change from baseline in left ventricular mass after 52 weeks
Change from baseline in diastolic function after 52 weeks
Change from baseline in markers of fibrosis and increased heart size after 52 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals

🇺🇸

East Hanover, New Jersey, United States

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