Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)

Study Overview
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Brief Summary
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This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.

Official Title
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A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Losartan 50 mg
* Drug: Losartan 150 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure May or may not be receiving an alternative and/or additional drug treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan 50 mg<br>50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years) | Drug: Losartan 50 mg<br>* 50-mg losartan oral tablet<br>* Other names: Losartan potassium;|
| Experimental: Losartan 150 mg<br>Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan | Drug: Losartan 150 mg<br>* 100-mg losartan oral tablet + 50-mg losartan oral tablet<br>* Other names: Losartan potassium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure |  | Entire follow-up (median = 4.7 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization | Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure. | Entire follow-up (median = 4.7 years) | 
| Number of Participants That Died (Any Cause) |  | Entire follow-up (median = 4.7 years) | 
| Number of Participants That Were Hospitalized for Heart Failure |  | Entire follow-up (median = 4.7 years) | 
| Number of Participants That Experienced Cardiovascular Hospitalization |  | Entire follow-up (median = 4.7 years) |