Coronary Artery DiseaseNCT03620539
Sauna Bathing to Improve Vascular Health of Adults With Heart Disease
A study testing Lifestyle intervention in people with Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
This study is a clinical trial that will determine if sauna bathing improves blood vessel health in adults aged 50-70 years with heart disease. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2018to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of angiographic coronary disease: ≥70% arterial diameter narrowing of at least one major epicardial coronary artery and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during exercise testing or pharmacological stimulation
- Stable medication doses (≥4 weeks) prior to enrolment
- Body mass index <35 kg/m2
Who cannot join
- Recent (<3 months) coronary artery disease-related hospitalization or change in angina pattern
- Unstable angina
- Ejection fraction <40% and/or clinical evidence of heart failure
- Significant valvular heart disease
- Uncontrolled hypertension (>180/110 mmHg)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: Effects of Sauna Bathing on Cerebrovascular Function in Middle-aged to Older Adults With Heart Disease
This study is a clinical trial that will determine if sauna bathing improves blood vessel health in adults aged 50-70 years with heart disease.
Read the detailed description
Mounting evidence suggests that heat therapy may improve cardiovascular health. Recent analyses of a large cohort of middle-aged to older Finnish men have established that frequent sauna bathing is associated with a reduced risk of cardiovascular mortality, of developing dementia and Alzheimer's disease, and of developing hypertension. Given the observational nature of these relationships, it remains unknown if the beneficial effects of sauna bathing can be directly attributed to heat exposure.
The objective of this study is to test the primary hypothesis that 8 weeks of sauna bathing improves flow-mediated dilation, a measure of blood vessel health, in middle-aged to older adults (50-70 yrs) with stable coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Lifestyle intervention
- Keywords
- flow-mediated dilation, sauna, vascular, heat
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
Sauna bathing
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized to the control condition will be asked to maintain their normal daily habits. |
| Sauna | Experimental | The sauna intervention will consist of 20 to 30 minute sauna bathing sessions within a dry Finnish sauna, performed 4 times per week. Receives: Other: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion
Measured: Change from baseline after 8 weeks
Secondary outcomes (3)
Post-occlusion reactive hyperaemia (AUC)
Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion
Measured: Change from baseline after 8 weeks
Post-occlusion reactive hyperaemia (Peak)
Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion
Measured: Change from baseline after 8 weeks
Local skin heating-induced vasodilation
Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C
Measured: Change from baseline after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start4 Dec 2018
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Gagnon, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620539
- Sponsor's protocol ID
- ICM2017-2312
- Status last verified
- Oct 2023
- First submitted
- 24 Jul 2018
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debray A, Gravel H, Garceau L, Bartlett AA, Chaseling GK, Barry H, Behzadi P, Ravanelli N, Iglesies-Grau J, Nigam A, Juneau M, Gagnon D. Finnish sauna bathing and vascular health of adults with coronary artery disease: a randomized controlled trial. J Appl Physiol (1985). 2023 Oct 1;135(4):795-804. doi: 10.1152/japplphysiol.00322.2023. Epub 2023 Aug 31.
PubMed 37650138
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sauna Bathing on Cerebrovascular Function in Middle-aged to Older Adults With Heart Disease
- ClinicalTrials.gov ID
- NCT03620539
- Acronym / sponsor ID
- ICM2017-2312
- Conditions
- Coronary Artery Disease
- Keywords
- flow-mediated dilation, sauna, vascular, heat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 8 Aug 2018 (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.
This study is a clinical trial that will determine if sauna bathing improves blood vessel health in adults aged 50-70 years with heart disease.
Detailed description
Mounting evidence suggests that heat therapy may improve cardiovascular health. Recent analyses of a large cohort of middle-aged to older Finnish men have established that frequent sauna bathing is associated with a reduced risk of cardiovascular mortality, of developing dementia and Alzheimer's disease, and of developing hypertension. Given the observational nature of these relationships, it remains unknown if the beneficial effects of sauna bathing can be directly attributed to heat exposure.
The objective of this study is to test the primary hypothesis that 8 weeks of sauna bathing improves flow-mediated dilation, a measure of blood vessel health, in middle-aged to older adults (50-70 yrs) with stable coronary artery disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to the control condition will be asked to maintain their normal daily habits. |
| Sauna | Experimental | Other: Lifestyle interventionThe sauna intervention will consist of 20 to 30 minute sauna bathing sessions within a dry Finnish sauna, performed 4 times per week. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A history of angiographic coronary disease: ≥70% arterial diameter narrowing of at least one major epicardial coronary artery and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during exercise testing or pharmacological stimulation
- Stable medication doses (≥4 weeks) prior to enrolment
- Body mass index <35 kg/m2
Key exclusion criteria (5 listed)
- Recent (<3 months) coronary artery disease-related hospitalization or change in angina pattern
- Unstable angina
- Ejection fraction <40% and/or clinical evidence of heart failure
- Significant valvular heart disease
- Uncontrolled hypertension (>180/110 mmHg)
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 |
|---|---|---|
| Lifestyle interventionSauna bathing | Other | Sauna |
Primary outcome
Flow-mediated dilation
Time frame: Change from baseline after 8 weeks
Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion
3 secondary outcomes
Post-occlusion reactive hyperaemia (AUC)
Time frame: Change from baseline after 8 weeks
Post-occlusion reactive hyperaemia (Peak)
Time frame: Change from baseline after 8 weeks
Local skin heating-induced vasodilation
Time frame: Change from baseline after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Results publication: PubMed 37650138Debray A, Gravel H, Garceau L, Bartlett AA, Chaseling GK, Barry H, Behzadi P, Ravanelli N, Iglesies-Grau J, Nigam A, Juneau M, Gagnon D. Finnish sauna bathing and vascular health of adults with coronary artery disease: a randomized controlled trial. J Appl Physiol (1985). 2023 Oct 1;135(4):795-804. doi: 10.1152/japplphysiol.00322.2023. Epub 2023 Aug 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
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 3 inclusion and 5 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 31 Oct 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flow-mediated dilation (time frame: Change from baseline after 8 weeks). 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 NCT03620539, 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 31 Oct 2023.