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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03620539
Other study ID # ICM2017-2312
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date September 12, 2022

Study information

Verified date October 2023
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 12, 2022
Est. primary completion date September 12, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: 1. 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 2. Stable medication doses (=4 weeks) prior to enrolment 3. Body mass index <35 kg/m2 Exclusion Criteria: 1. Recent (<3 months) coronary artery disease-related hospitalization or change in angina pattern 2. Unstable angina 3. Ejection fraction <40% and/or clinical evidence of heart failure 4. Significant valvular heart disease 5. Uncontrolled hypertension (>180/110 mmHg)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lifestyle intervention
Sauna bathing

Locations

Country Name City State
Canada Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 App — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure Systolic blood pressure at rest Change from baseline after 8 weeks
Other Central arterial stiffness Carotid-femoral pulse wave velocity Change from baseline after 8 weeks
Other Heart rate variability Resting levels of heart rate variability Change from baseline after 8 weeks
Primary Flow-mediated dilation Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion Change from baseline after 8 weeks
Secondary Post-occlusion reactive hyperaemia (AUC) Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion Change from baseline after 8 weeks
Secondary Post-occlusion reactive hyperaemia (Peak) Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion Change from baseline after 8 weeks
Secondary Local skin heating-induced vasodilation Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C Change from baseline after 8 weeks
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