Hypertension, Left Ventricular Hypertrophy
Conditions
Keywords
Hypertension, Left ventricular hypertrophy
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in left ventricular mass index after 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in left ventricular mass after 52 weeks | — |
| Change from baseline in diastolic function after 52 weeks | — |
| Change from baseline in aorta function assessed blood pressure measurements after 52 weeks | — |
| Change from baseline in markers of fibrosis and increased heart size after 52 weeks | — |
Countries
United States
Outcome results
None listed