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Study has been terminated early due to financial constraints.
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This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alagebrium | Drug | 200 mg (two 100 mg tablets) two times daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test | Assessed at baseline, week 12 and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| QOL as assessed by the Kansas City Cardiomyopathy Questionnaire | baseline, week 12 and week 24 | |
| To assess New York Heart Association Classification | Baseline, week 12 and week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertram Pitt, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| placebo | Drug | placebo tablets - two tablets taken twice daily |
|
| To evaluate cardiovascular death or hospitalization for heart failure |
| Will be assessed during the entire 24 wk trial |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Mobile | Alabama | 36608 | United States |
| Anaheim | California | United States |
| Bakersfield | California | 93308 | United States |
| La Jolla | California | 92037 | United States |
| Roseville | California | 95661 | United States |
| Jacksonville | Florida | 32209 | United States |
| Miami | Florida | 33136 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Covington | Georgia | 30014 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Louisville | Kentucky | 40207 | United States |
| Auburn | Maine | 04210 | United States |
| South Portland | Maine | 04106 | United States |
| Ayer | Massachusetts | 01432 | United States |
| Lincoln | Nebraska | 68506 | United States |
| Ridgewood | New Jersey | 07450 | United States |
| Albany | New York | 12205 | United States |
| Stony Brook | New York | 11794 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Dayton | Ohio | 45414 | United States |
| Fairfield | Ohio | 45014 | United States |
| Sandusky | Ohio | 44870 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Charleston | South Carolina | 29401 | United States |
| Germantown | Tennessee | 38138 | United States |
| Lackland Airforce Base | Texas | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C406794 | alagebrium |
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