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.

Hypertension Clinical Trial

Official title:

A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170924
• Other study ID #: CVAL489AUS52
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: November 7, 2011
• Start date: August 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Hypertension

Intervention

Drug:
• Valsartan

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
Secondary	Change from baseline in the wall thickness of left heart ventricle after 38 weeks
Secondary	Change from baseline in the size (mass) left heart ventricle after 38 weeks
Secondary	Change from baseline in heart function after 38 weeks
Secondary	Change from baseline in circulating marker of ventricular function after 38 weeks
Secondary	Change from baseline in circulating marker of inflammation

External Links

•   Novartis Patient Recruitment Website