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Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction (Moderate)

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Alcohol consumption
Sponsored by
Baris Gencer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening Men and women aged ≥18 years who are capable and willing to provide consent ECG ischemic changes, such as persistent or dynamic ST-segment deviation Evidence of positive high-sensitive troponin Confirmation of coronary heart disease aetiology by angiography Capacity to complete study visits with strict adherence to the protocol assignment Self-reported average alcohol consumption of between 4 and 28 standard units per week in the 12 months prior to the index hospitalization. Exclusion Criteria: High alcohol consumption, defined as an average of >21 alcoholic standard units/week in the 12 months prior to the index hospitalization Alcohol use disorder (AUDIT score >20 at screening) History of alcohol or substance abuse Naïve to alcohol consumption Light alcohol consumption (<4 standard units by week) Prior severe heart failure (NYHA III-IV) Severe LV dysfunction at screening (<40%) History of gastric ulcer or gastro-intestinal bleeding Serious chronic liver disease or liver test elevation (> 3 times upper limit normal range) Personal history of any colon or liver cancer Any active malignancy (less than 5 years or ongoing treatment) Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease Any medication (investigator's discretion) making study participation impractical or precluding required follow-up History of organ transplant Participation in another trial testing intervention on similar CV outcomes (investigator's discretion) Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.

Sites / Locations

  • InselspitalRecruiting
  • Hôpitaux Universitaires de GenèveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Moderate alcohol consumption

Abstinence

Arm Description

1 standard unit a day for 12 months

No alcohol beverages for 12 months

Outcomes

Primary Outcome Measures

Cardiac function
Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
June 16, 2023
Sponsor
Baris Gencer
Collaborators
University of Bern, Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05920629
Brief Title
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
Acronym
Moderate
Official Title
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Baris Gencer
Collaborators
University of Bern, Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A total of 220 patients (110 per arm) who report moderate alcohol consumption between 4 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 for 12 months) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 12 months. An echocardiography will be performed at baseline and 12 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate alcohol consumption
Arm Type
No Intervention
Arm Description
1 standard unit a day for 12 months
Arm Title
Abstinence
Arm Type
Other
Arm Description
No alcohol beverages for 12 months
Intervention Type
Behavioral
Intervention Name(s)
Alcohol consumption
Intervention Description
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 12 months. We will perform a first echocardiography at randomization and a second at 12 months' follow-up.
Primary Outcome Measure Information:
Title
Cardiac function
Description
Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening Men and women aged ≥18 years who are capable and willing to provide consent ECG ischemic changes, such as persistent or dynamic ST-segment deviation Evidence of positive high-sensitive troponin Confirmation of coronary heart disease aetiology by angiography Capacity to complete study visits with strict adherence to the protocol assignment Self-reported average alcohol consumption of between 4 and 28 standard units per week in the 12 months prior to the index hospitalization. Exclusion Criteria: High alcohol consumption, defined as an average of >21 alcoholic standard units/week in the 12 months prior to the index hospitalization Alcohol use disorder (AUDIT score >20 at screening) History of alcohol or substance abuse Naïve to alcohol consumption Light alcohol consumption (<4 standard units by week) Prior severe heart failure (NYHA III-IV) Severe LV dysfunction at screening (<40%) History of gastric ulcer or gastro-intestinal bleeding Serious chronic liver disease or liver test elevation (> 3 times upper limit normal range) Personal history of any colon or liver cancer Any active malignancy (less than 5 years or ongoing treatment) Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease Any medication (investigator's discretion) making study participation impractical or precluding required follow-up History of organ transplant Participation in another trial testing intervention on similar CV outcomes (investigator's discretion) Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baris Gencer, MD
Phone
+4179 55 35 927
Email
baris.gencer@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baris Gencer, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenz Raber
Email
lorenz.raeber@insel.ch
Facility Name
Hôpitaux Universitaires de Genève
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baris Gencer
Email
baris.gencer@hcuge.ch

12. IPD Sharing Statement

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Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction

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