Myocardial InfarctionModerateNCT05920629
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
A study testing Alcohol consumption in people with Myocardial Infarction, run by Baris Gencer at 4 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Alcohol consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Jun 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 1 and 28 standard units per week in the 12 months prior to the index hospitalization.
Who cannot join
- High alcohol consumption, defined as an average of >28 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 (<1 standard units by week)
- Prior severe heart failure (NYHA III-IV)
Show all 17Show fewer
- Severe LV dysfunction at screening (<30%)
- 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.
- Pregnant, breastfeeding or planning to become pregnant within 12 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Universitätsspital Basel
Basel, Basel, 4031
Christian Müller, Prof Dr, Christian.Mueller@usb.ch
- Recruiting
Inselspital
Bern, Canton of Bern, 3010
Lorenz Raber, lorenz.raeber@insel.ch
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, 1205
François Mach, francois.mach@hug.ch
- Recruiting
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, 1005
Baris Gencer, baris.gencer@chuv.ch
About this study
Official title: Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
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.
- Conditions
- Myocardial Infarction
- Being tested
- Alcohol consumption
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol consumptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate alcohol consumption | No intervention | 1 standard unit a day for 3 months |
| Abstinence | Other | No alcohol beverages for 3 months Receives: Behavioral: Alcohol consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function
Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baris Gencer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Baris Gencer, University Hospital, Geneva
- Investigators
- Baris Gencer, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920629
- Sponsor's protocol ID
- 2022-01838
- Acronym
- Moderate
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05920629
- Acronym / sponsor ID
- Moderate / 2022-01838
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Baris GencerUniversity, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate alcohol consumption | No intervention | –1 standard unit a day for 3 months |
| Abstinence | Other | Behavioral: Alcohol consumptionNo alcohol beverages for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- High alcohol consumption, defined as an average of >28 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 (<1 standard units by week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol consumptionAfter 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. | Behavioural | Abstinence |
Primary outcome
Cardiac function
Time frame: 3 months
Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baris Gencer, MD principal investigator
CHUV
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol consumption in people with Myocardial Infarction, run by Baris Gencer at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baris Gencer, MD (+41 79 556 59 60, baris.gencer@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.