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.

Condition(s) targeted: Diastolic Dysfunction; Hypertension

Intervention: Valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Secondary outcome:

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

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Novartis Patient Recruitment Website

Starting date: August 2004
Last updated: February 16, 2007