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| Name | Class |
|---|---|
| University of Bern | OTHER |
| Swiss National Science Foundation | OTHER |
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A total of 220 patients (110 per arm) who report moderate alcohol consumption between 1 and 28 standard units (1 standard unit = ~10 grams) per week in the 12 months prior to hospital admission will be planned for randomization, using a 1:1 ratio to pursue moderate alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 3 months. An echocardiography will be performed at baseline and 3 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate alcohol consumption | No Intervention | 1 standard unit a day for 3 months | |
| Abstinence | Other | No alcohol beverages for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol consumption | Behavioral | After written consent, patients will enter a run-in period of 2 weeks where they will be asked not to drink any alcohol beverage. Patients with a successful run-in period will be randomized on a 1:1 basis stratified by baseline LVEF (<50% vs. ≥50%), sex and study site. 110 patients will be assigned to moderate alcohol consumption (1 standard unit a day), and 110 patients to abstinence (no alcohol beverages) for 3 months. We will perform a first echocardiography at randomization and a second at 3 months' follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function | Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baris Gencer, MD | Contact | +41 79 556 59 60 | baris.gencer@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Baris Gencer, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Basel | Recruiting | Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Inselspital | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
|
| Centre hospitalier universitaire vaudois | Recruiting | Lausanne | Canton of Vaud | 1005 | Switzerland |
|
| Hôpitaux Universitaires de Genève | Recruiting | Geneva | 1205 | Switzerland |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |