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.

Novartis317 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

317

Conditions

Diastolic Dysfunction Hypertension

Interventions

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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