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Completed

NCT Number: NCT06583161

Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)

The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank.

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Key information

Conditions

Myocardial Infarction All-Cause Mortality Angina Pectoris Arrhythmias, Cardiac Atrial Fibrillation Behavior Behavioral Symptoms Brain Diseases Cancer Cardiovascular Death Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chest Pain Coronary Revascularization Dementia Depression Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fibrosis Glucose Metabolism Disorders Heart Diseases Heart Failure Infarction Infections Injuries Ischemia Ischemic Stroke Liver Cirrhosis Liver Diseases Mental Disorders Metabolic Diseases Myocardial Ischemia Necrosis Neoplasms Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Type 2 Diabetes Vascular Diseases Wounds and Injuries

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Observational

About this study

Observational data suggests that alcohol consumption lowers the risk of cardiovascular disease (CVD) compared to no consumption. Whether this relationship is truly causal remains uncertain because of the inherent limitations of observational studies, including unmeasured confounding and reverse causation. Mendelian randomization studies using genes as instrumental variables for alcohol are partially protected from these biases and have found no or harmful associations between alcohol consumption and CVD.

To date, there has only been one long-term randomized controlled trial to investigate the cardiovascular effects of alcohol consumption: the Moderate Alcohol and Cardiovascular Health Trial (MACH15; NCT Number: NCT03169530). It was, however, terminated shortly after initiation. An alternative to a real randomized trial like MACH15, which must first be completed and is subject to strict eligibility criteria to ensure safety, is to use observational data to emulate a (hypothetical) pragmatic randomized trial.

In this study, the investigators will emulate an adapted version of MACH15 using observational data from the UK Biobank, a large prospective cohort study of over 500,000 participants. The cardiometabolic effects of moderate drinking vs quitting, as originally planned in MACH15, as well as the effects of social and heavy/binge drinking on CVD, type 2 diabetes, other alcohol-related health outcomes, and death will be quantified.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40-69 years old at enrollment
  • Currently drinking

Exclusion criteria

  • Within the six months prior to baseline, cardiovascular disease event (myocardial infarction, revascularization procedure, or stroke)
  • Hospitalization due to heart failure
  • History of any of the following alcohol-related conditions, confirmed by a hospital record: alcoholic cardiomyopathy, alcoholic gastritis, alcoholic liver disease, degeneration of the nervous system due to alcohol, alcoholic myopathy, alcoholic polyneuropathy, alcohol-induced acute or chronic pancreatitis, alcohol use disorder; or self-reported history of alcoholic liver disease or alcohol use disorder
  • Dual antiplatelet therapy or coumarin anticoagulants
  • Serious chronic liver disease (active hepatitis B or C infection) in the past 6 months before baseline
  • Personal history of any colon or liver cancer
  • Personal history of breast cancer
  • Diagnosis of dementia
  • Not willing or able to provide a signed and dated informed consent form
  • Reduced alcohol compared to 10 years ago due to illness, ill health, or doctor's advice
  • Self-reported poor health

Treatment and study plan

Moderate drinking

Behavioral

Drink up to 16 grams of alcohol daily or almost daily [repeated assessment center visit] or 8-16 grams of alcohol 4 or more times per week [web-based mental health questionnaire]

Quitting

Behavioral

No alcohol consumption

Social drinking

Behavioral

Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions [repeated assessment center visit], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less [web-based mental health questionnaire]

Heavy/binge drinking

Behavioral

Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week [repeated assessment center visit], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week [web-based mental health questionnaire]

Primary outcomes

  1. Cardiovascular disease or death

    Time frame: From date of baseline measurement until the date of first cardiovascular disease or death documented in hospital or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months

    Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and all-cause mortality

Secondary outcomes

  1. Cardiovascular disease

    Time frame: From date of baseline measurement until the date of first cardiovascular disease documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

    Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and cardiovascular death

  2. Type 2 diabetes

    Time frame: From date of baseline measurement until the date of first type 2 diabetes documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

    Progression among normoglycemic and pre-diabetes individuals to type 2 diabetes

  3. Alcohol-related disease or death

    Time frame: From date of baseline measurement until the date of first alcohol-related disease or death documented in hospital, cancer, or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months

    Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, heart failure, atrial fibrillation, cancer (except non-melanoma skin cancer), dementia, depression, infection with hospitalization, injury with hospitalization, liver cirrhosis, type 2 diabetes, and all-cause mortality

Other outcomes

  1. Hard cardiovascular disease or death

    Time frame: From date of baseline measurement until the date of first hard cardiovascular disease or death documented in hospital or death registry data, admin. censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

    Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, and cardiovascular death

  2. Cardiovascular death

    Time frame: From date of baseline measurement until the date of cardiovascular death documented in death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

    Cardiovascular death

  3. Non-fatal myocardial infarction

    Time frame: From date of baseline measurement until the date of first non-fatal myocardial infarction documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months

    First occurrence of a non-fatal myocardial infarction

  4. Non-fatal ischemic stroke

    Time frame: From date of baseline measurement until the date of first non-fatal ischemic stroke documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months

    First occurrence of a non-fatal ischemic stroke

  5. Hospitalization for angina

    Time frame: From date of baseline measurement until the date of first hospitalization for angina documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months

    First hospitalization for angina

  6. Coronary/carotid revascularization

    Time frame: From date of baseline measurement until the date of first coronary/carotid revascularization documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months

    First coronary/carotid revascularization

  7. All-cause mortality

    Time frame: From date of baseline measurement until the date of death documented in death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months

    Death

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Important dates

Study start
2006
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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