Reducing Cardiovascular Risks: The Role of Alcohol Use

NCT07783061 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0383
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke. In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups. The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.

Conditions

Alcohol Drinking; Drinking Behavior; At-risk Drinking; Cardiovascular Risk Factor; High Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Change in in-laboratory central and peripheral blood pressure

  In-laboratory central blood pressure will be measured after a 10-min rest in supine position, while in-laboratory peripheral blood pressure will be measured after a 10-min rest in seated position.

  Baseline and after the 8-week intervention

• Change in nighttime central and peripheral blood pressure

  Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.

  Baseline and after the 8-week intervention

Secondary Outcomes (3)

• Change in arterial stiffness

  Baseline and after the 8-week intervention

• Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)

  Baseline and after the 8-week intervention

• Change in muscle sympathetic nerve activity (MSNA)

  Baseline and after the 8-week intervention

Other Outcomes (1)

• Objective sleep

  During the study participation (10 weeks).

Study Arms (2)

Usual Drinking Habits (Control)

OTHER

Participants will continue their usual alcohol consumption patterns during the study period and will be instructed not to change their lifestyle including alcohol use, diet, and habitual physical activity.

Other: Control arm

Alcohol Abstinence Intervention

EXPERIMENTAL

Participants will be instructed to abstain from alcohol for 8 weeks. Throughout the study period, participants will be asked to maintain their usual diet and level of physical activity and avoid making other lifestyle changes, except for abstaining from alcohol.

Behavioral: Alcohol Abstinence

Interventions

Alcohol Abstinence BEHAVIORAL

Participants will be instructed to abstain from alcohol for 8 weeks and maintain their usual lifestyle, including diet and physical activity. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to receive educational materials and personalized feedback based on phosphatidylethanol (PEth), sleep, and heart rate variability data to support alcohol abstinence. During these meetings, participants will also complete assessments of alcohol use, physical activity, and dietary intake. At week 4, participants will complete a dried blood spot PEth test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.

Alcohol Abstinence Intervention

Control arm OTHER

Participants will be asked to maintain their usual lifestyle, including alcohol consumption, diet, and physical activity, and will not have access to their study data during the intervention. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to complete questionnaires on alcohol use, physical activity, and diet. At week 4, participants will complete a dried blood spot phosphatidylethanol (PEth) test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.

Usual Drinking Habits (Control)

Eligibility Criteria

• Age: 26 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 26 to 49 years
• At-risk drinkers who drink over the recommended limits, defined as those with PEth (≥20 ng/dL) or those with a U.S. Alcohol Use Disorders Identification Test (USAUDIT) score ≥8/7 for men/women
• Elevated blood pressure or hypertension (systolic blood pressure: 120-160 mmHg and/or diastolic blood pressure 80-100 mmHg)

You may not qualify if:

• History of CVD or cardiovascular events (e.g., stroke, myocardial infarction)
• The presence of myocardial ischemia or arrhythmias with abnormal ECG and blood pressure during a clinically-supervised maximal graded exercise test
• Hypertension (systolic \>160 mmHg and diastolic \>100 mmHg)
• On more than one anti-hypertensive medication, or on other physician-prescribed medications (but not including oral contraceptives)
• Major psychiatric disorders, including autism, ADHD, bipolar disorder, major depression, schizophrenia, and substance use disorders
• Alcohol use disorder, PEth ≥400 ng/mL, or USAUDIT score ≥ 25
• Current or history of any tobacco use in the past 6 months (including, but not limited to, cigarettes, e-cigarettes, hookah, Nicorette, snus and chewing tobacco)
• Current or history of illicit and recreational drug use (more than 3 times in the past month and more than 15 times in their lifetime)
• Diabetes type 1 \& type 2 with fasting blood glucose ≥126 mg/dL
• Presence of renal disease with a creatinine \> 1.5 mg/dL
• Presence of liver disease with liver enzymes \> 3x the upper limits of normal
• Anemia with a hemoglobin \< 8 g/dL
• Diagnosis of chronic inflammatory disease such as, but not limited to, cancer
• Diagnosis of chronic autoimmune diseases such as, but not limited to lupus, multiple sclerosis, rheumatoid arthritis
• Diagnosis of chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, lung cancer, and cystic fibrosis

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington

Arlington, Texas, 76010, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Drinking Behavior; Hypertension

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Chueh-Lung Hwang, PhD, PT

CONTACT

8172729722; chuehlung.hwang@uta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Submit a Data Access Request to NDA and get approval.

Locations

US (1)