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Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

NCT03186976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-12-18

No results posted yet for this study

Summary

This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (AF).

Conditions

Interventions

BEHAVIORAL

Aggressive Risk Factor Control

1.) Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5. 2\) Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (\>5 drinks at one setting). 3\) Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise. 4\) An OMRON BP monitor will be supplied to each patient. A target SBP of \<140/80 mm/Hg will be targeted. 5\) Smoking cessation - through local resources already established at each site 6) Management of diabetes to achieve HgA1c\<6.5%

OTHER

Standard of Care

Recommendations based on current guidelines

Sponsors & Collaborators

  • Canadian Cardiovascular Society

    collaborator OTHER

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Ratika Parkash · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-10-31
Completion
2019-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186976 on ClinicalTrials.gov