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OpenTrials
Completed

NCT Number: NCT00139555

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

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Amlodipine/benazepril

Drug

Primary outcomes

  1. Change from baseline in left ventricular mass index after 52 weeks

Secondary outcomes

  1. Change from baseline in left ventricular mass after 52 weeks

  2. Change from baseline in diastolic function after 52 weeks

  3. Change from baseline in aorta function assessed blood pressure measurements after 52 weeks

  4. Change from baseline in markers of fibrosis and increased heart size after 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
Feb 23, 2017

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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