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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.
Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Active Comparator | Spironolactone used according to heart failure guidelines |
|
| Eplerenone | Active Comparator | Eplerenone used according to heart failure guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | Eplerenone according to guidelines |
| |
| Spironolactone |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality (will be used if overall mortality rate is 15% or greater) | 5 years |
| Mortality or hospitalization for heart failure | Will be used if overall mortality is less than 15% | 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Jakob Thune, MD, PhD | Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
Data is located on research servers with Statistics Denmark. Individual participant data may not be exported from the servers.
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| Drug |
Spironolactone according to guidelines |
|
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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