A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

Novartis160 enrolled

Overview

This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Chronic Heart Failure

Interventions

valsartan 160 mgDRUG

valsartan 160 mg BIDDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Males or females aged 18 years or older * Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1 * Patients must remain on their prior standard care CHF therapy Exclusion Criteria * Diagnosis of severe hypertension (SBP\>180 and DBP\>110 mm Hg) * Right heart failure due to pulmonary disease * Presence of rapidly deteriorating heart failure * MI or cardiac surgery, including PTCA within 3 months of Visit 1 * Unstable angina or coronary artery disease likely to require CABG or PTCA * Other protocol-defined exclusion criteria may apply.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure

Secondary Outcomes

Patients reaching target dose at 10 weeks

Change from baseline in systolic blood pressure at each study visit

Change from baseline in diastolic blood pressure at each study visit

Change from baseline in blood potassium at each study visit

Change from baseline in blood creatinine at each study visit

Data from ClinicalTrials.gov

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