Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

Hypertension Clinical Trial

— AF  

Official title:

Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910192
• Other study ID #: 0031-1617
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: York University
• Contact: Paul Ritvo, Ph.D
• Phone: 416-736-2100
• Email: pritvo[@]yorku.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program.

Both groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks).

In addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 50-80

• Diagnosed Atrial Fibrillation

• Night time (Sleep Time) Systolic Blood Pressure=120 OR Daytime (awake) Systolic Blood Pressure = 135

• Able and Willing to sign Informed Consent Form

Exclusion Criteria:

• Scheduled for Surgery

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Risk Reduction
• Hypertension
• Mindfulness

Intervention

Behavioral:
• Mindfulness-based coaching
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
• Dietary cardiovascular risk reduction coaching
Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	Southlake Regional Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Night time (Sleep) Systolic Blood Pressure	The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.	16 weeks
Primary	Daytime time (Awake) Systolic Blood Pressure	The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.	16 Weeks
Secondary	Nocturnal Dipping	ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values	16 Weeks
Secondary	Atrial Tachyarrhythmia Episodes	24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more	16 Weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations	16 Weeks
Secondary	Profile of Mood States (POMS-SF)	65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings	16 Weeks
Secondary	Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)	24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.	16 Weeks
Secondary	SF-12 v2 Health Survey	assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).	16 Weeks
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.	16 Weeks
Secondary	Cardiac Anxiety Questionnaire (CAQ)	18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.	16 Weeks