Atrial FibrillationHOLIDAYNCT01996943
The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study
A study testing Ethanol in people with Atrial Fibrillation and Alcohol, run by University of California, San Francisco at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it has been associated with ethanol use. Understanding how ethanol affects the electrical properties of the heart and induces AF has important public health implications. Read more about this study
- Who is it for?
- Ages 21 to 81 years
- Conditions the study is for
- Atrial Fibrillation, Alcohol
- What is being tested?
- Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21-80 with paroxysmal atrial fibrillation (AF), supraventricular tachycardia, or undifferentiated palpitations who are to undergo either an elective ablation procedure (for AF, atrial flutter, atria tachycardia, atrial ventricular nodal reentrant tachycardia (AVNRT), or atrial ventricular reentrant tachycardia (AVRT)) or a diagnostic electrophysiology study in order to diagnose and treat their clinical arrhythmia at the University of California, San Francisco (UCSF) will be eligible for enrollment.
Who cannot join
- Patients will be excluded if they are not in normal sinus rhythm (i.e. in AF, atrial tachycardia, atrial flutter, or incessant AVNRT/AVRT) at the time of onset of the procedure, any history of substance abuse or alcoholism as determined by history, AUDIT questionnaire, or chart review, left ventricular ejection fraction <50%, inability to give informed consent, liver dysfunction (elevated aspartate aminotransferase , alanine aminotransferase, total bilirubin, or alkaline phosphatase >2x normal), clinical evidence of liver disease (enlarged liver, caput medusa, spider angiomas, or other signs of liver disease on exam), or pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Investigating the Effects of Ethanol on Atrial Fibrillation Susceptibility and Pathogenesis
Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it has been associated with ethanol use. Understanding how ethanol affects the electrical properties of the heart and induces AF has important public health implications. The objective of this research is to investigate the mechanistic relationship between ethanol and atrial fibrillation in humans by performing a placebo controlled study looking at the electrical properties of the heart in patients receiving intravenous ethanol or placebo. The investigators hypothesize that ethanol increases the susceptibility of human myocardium to atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute setting.
Read the detailed description
The purpose of this study is to look for changes in the electrical properties of heart that may be caused by ethanol (commonly referred to as alcohol) and specifically how ethanol may trigger episodes of the most common abnormal heart rhythm, atrial fibrillation (AF). This study will demonstrate the mechanism of ethanol induced atrial fibrillation and clarify the health effects of one of the worlds' most popular drugs (ethanol). With this understanding, physicians may be able to better identify those patients most at risk for ethanol induced AF and target public health campaigns towards this vulnerable population.
Patients in this study will undergo an electrophysiologic study both prior to and after receiving either an ethanol or placebo infusion. This electrophysiology study will measure AF inducibility (the primary outcome), left and right atrial conduction times, and the atrial effective refractory period in multiple locations (AERP). The changes in the conduction times and AERPs (before and after study drug infusion) will be recorded as secondary outcomes.
About 100 people will participate in this study. 50 people will be randomized to receive intravenous ethanol, and 50 people will be randomized to receive an intravenous placebo. The placebo will be in the form of 0.45% saline solution ("half normal saline") and the alcohol will be in the form of 6% volume/volume ethanol in 0.45% saline solution.
- Conditions
- Atrial Fibrillation, Alcohol
- Being tested
- Ethanol, Placebo
- Keywords
- Atrial Fibrillation, Alcohol, Electrophysiologic properties of the atria, Randomized Clinical Study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Also called Alcohol
6% volume/volume ethanol in 0.45% saline solution.
PlaceboDrug
Also called Saline
The placebo with be 0.45% saline solution ("half normal saline").
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. Receives: Drug: Placebo |
| Ethanol | Active comparator | Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded. Receives: Drug: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Atrial Fibrillation Induction
Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.
Measured: This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.
Secondary outcomes (2)
Change in Conduction Time
The atrial conduction time will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in Conduction Time
Measured: This will be assessed during the experimental study from the Conduction Times that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.
Change in Atrial Effective Refractory Period (AERP)
The AERP will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in AERP
Measured: This will be assessed during the experimental study from the AERPs that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gregory M Marcus, MD, MAS, Principal investigator, University of California, San FranciscoJonathan W Dukes, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996943
- Sponsor's protocol ID
- 12-08579
- Other IDs
- 1R01AA022222-01
- Acronym
- HOLIDAY
- Status last verified
- Mar 2021
- First submitted
- 30 Sep 2013
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marcus GM, Dukes JW, Vittinghoff E, Nah G, Badhwar N, Moss JD, Lee RJ, Lee BK, Tseng ZH, Walters TE, Vedantham V, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Hue T, Olgin JE, Scheinman MM, Hsia H, Ramchandani VA, Gerstenfeld EP. A Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Alcohol to Assess Changes in Atrial Electrophysiology. JACC Clin Electrophysiol. 2021 May;7(5):662-670. doi: 10.1016/j.jacep.2020.11.026. Epub 2021 Jan 27.
PubMed 33516710
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Ethanol on Atrial Fibrillation Susceptibility and Pathogenesis
- ClinicalTrials.gov ID
- NCT01996943
- Acronym / sponsor ID
- HOLIDAY / 12-08579
- Conditions
- Atrial Fibrillation, Alcohol
- Keywords
- Atrial Fibrillation, Alcohol, Electrophysiologic properties of the atria, Randomized Clinical Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2012
- Primary completion
- May 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it has been associated with ethanol use. Understanding how ethanol affects the electrical properties of the heart and induces AF has important public health implications. The objective of this research is to investigate the mechanistic relationship between ethanol and atrial fibrillation in humans by performing a placebo controlled study looking at the electrical properties of the heart in patients receiving intravenous ethanol or placebo. The investigators hypothesize that ethanol increases the susceptibility of human myocardium to atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute setting.
Detailed description
The purpose of this study is to look for changes in the electrical properties of heart that may be caused by ethanol (commonly referred to as alcohol) and specifically how ethanol may trigger episodes of the most common abnormal heart rhythm, atrial fibrillation (AF). This study will demonstrate the mechanism of ethanol induced atrial fibrillation and clarify the health effects of one of the worlds' most popular drugs (ethanol). With this understanding, physicians may be able to better identify those patients most at risk for ethanol induced AF and target public health campaigns towards this vulnerable population.
Patients in this study will undergo an electrophysiologic study both prior to and after receiving either an ethanol or placebo infusion. This electrophysiology study will measure AF inducibility (the primary outcome), left and right atrial conduction times, and the atrial effective refractory period in multiple locations (AERP). The changes in the conduction times and AERPs (before and after study drug infusion) will be recorded as secondary outcomes.
About 100 people will participate in this study. 50 people will be randomized to receive intravenous ethanol, and 50 people will be randomized to receive an intravenous placebo. The placebo will be in the form of 0.45% saline solution ("half normal saline") and the alcohol will be in the form of 6% volume/volume ethanol in 0.45% saline solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. |
| Ethanol | Active comparator | Drug: EthanolEthanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded. |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 21-80 with paroxysmal atrial fibrillation (AF), supraventricular tachycardia, or undifferentiated palpitations who are to undergo either an elective ablation procedure (for AF, atrial flutter, atria tachycardia, atrial ventricular nodal reentrant tachycardia (AVNRT), or atrial ventricular reentrant tachycardia (AVRT)) or a diagnostic electrophysiology study in order to diagnose and treat their clinical arrhythmia at the University of California, San Francisco (UCSF) will be eligible for enrollment.
Key exclusion criteria (1 listed)
- Patients will be excluded if they are not in normal sinus rhythm (i.e. in AF, atrial tachycardia, atrial flutter, or incessant AVNRT/AVRT) at the time of onset of the procedure, any history of substance abuse or alcoholism as determined by history, AUDIT questionnaire, or chart review, left ventricular ejection fraction <50%, inability to give informed consent, liver dysfunction (elevated aspartate aminotransferase , alanine aminotransferase, total bilirubin, or alkaline phosphatase >2x normal), clinical evidence of liver disease (enlarged liver, caput medusa, spider angiomas, or other signs of liver disease on exam), or pregnancy.
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 |
|---|---|---|
| EthanolAlso: Alcohol6% volume/volume ethanol in 0.45% saline solution. | Drug | Ethanol |
| PlaceboAlso: SalineThe placebo with be 0.45% saline solution ("half normal saline"). | Drug | Placebo |
Primary outcome
Number of Participants With Atrial Fibrillation Induction
Time frame: This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.
Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.
2 secondary outcomes
Change in Conduction Time
Time frame: This will be assessed during the experimental study from the Conduction Times that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.
Change in Atrial Effective Refractory Period (AERP)
Time frame: This will be assessed during the experimental study from the AERPs that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33516710Marcus GM, Dukes JW, Vittinghoff E, Nah G, Badhwar N, Moss JD, Lee RJ, Lee BK, Tseng ZH, Walters TE, Vedantham V, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Hue T, Olgin JE, Scheinman MM, Hsia H, Ramchandani VA, Gerstenfeld EP. A Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Alcohol to Assess Changes in Atrial Electrophysiology. JACC Clin Electrophysiol. 2021 May;7(5):662-670. doi: 10.1016/j.jacep.2020.11.026. Epub 2021 Jan 27.
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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. This study is not recruiting at the moment.
Gregory M Marcus, MD, MAS principal investigator
University of California, San Francisco
Jonathan W Dukes, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Atrial Fibrillation and Alcohol, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Atrial Fibrillation Induction (time frame: This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996943, which also lists 1 linked publication.
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 16 Mar 2021.