Status:
COMPLETED
HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Hypertension
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.
Eligibility Criteria
Inclusion
- Age 20 to 75 years
- Hypertension by ABPM at baseline (daytime \> 135/85 mmHg or 24-hour ABPM \> 130/80 mmHg)
Exclusion
- Use of antihypertensive within 6 months of the screening ABPM.
- Screening office BP \> 180/100 and ABPM \> 160/100 mmHg.
- Diabetes
- Secondary hypertension
- Renal disease (GFR \< 60 ml/min or overt nephropathy)
- History of heart attack
- Stroke or TIA or
- Re-vascularization procedure.
- Active malignant disease (except non-melanoma skin cancer)
- Epileptic seizure 6 months before the screening visit.
- Congestive heart failure
- Severe liver disease
- Pregnancy or lactation period
- Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
- Planned elective surgery during the study period except for cataract surgery
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00825526
Start Date
July 1 2008
Last Update
June 1 2012
Active Locations (2)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
2
University Health Network
Toronto, Ontario, Canada, M5G 2N2