To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.

Phase 4

Completed

• Conditions: Diastolic Dysfunction; Hypertension

• Registration Number: NCT00170924
• Lead Sponsor: Novartis

Brief Summary

Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.

This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Diagnosis/History of high blood pressure
• Male or Female age 45 years or older

Exclusion Criteria

• History of stroke, transient ischemic attack or heart attack within the last 6 months
• A hospital admission for congestive heart failure within the last year
• Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the wall thickness of left heart ventricle after 38 weeks
Change from baseline in the size (mass) left heart ventricle after 38 weeks
Change from baseline in heart function after 38 weeks
Change from baseline in circulating marker of ventricular function after 38 weeks
Change from baseline in circulating marker of inflammation

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States