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Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation

Primary Purpose

Congestive Heart Failure, Cardiac Resynchronization Therapy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vipassana Meditation practice and instruction
Standard Medical Care
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18 to 85
  • All patients with NYHA class II to III congestive heart failure symptoms from ischemic and non-ischemic etiology who received a defibrillator at least 3 months prior to enrollment.
  • All patients with NYHA class III and IV symptoms, QRS complex of the ECG more than 120 ms, who received device for cardiac resynchronization at least 3 months prior to enrollment. These devices are placed when the two ventricles beat at slightly different times. These devices also have the capacity to record arrhythmias as the defibrillators.

Exclusion Criteria:

  • Patients with life expectancy less than 6 months from non-cardiac causes
  • Pregnant women
  • Smokers
  • History of major psychosis.
  • Significant chronic liver, renal and pulmonary disease
  • Active alcohol and drug abuse

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meditation Cohort

Standard Care

Arm Description

25 patients will be given instruction in vipassana meditation. Vipassana meditation is thought to reduce the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure, and improve their overall psychological profile.

25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.

Outcomes

Primary Outcome Measures

Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.
Increase in heart rate variability for patients participating in vipassana meditation training.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2008
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00611260
Brief Title
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
Official Title
Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators. We wish to test the following hypotheses: Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure. Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).
Detailed Description
This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Cardiac Resynchronization Therapy
Keywords
Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Cohort
Arm Type
Experimental
Arm Description
25 patients will be given instruction in vipassana meditation. Vipassana meditation is thought to reduce the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure, and improve their overall psychological profile.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.
Intervention Type
Behavioral
Intervention Name(s)
Vipassana Meditation practice and instruction
Other Intervention Name(s)
Meditation + ICD
Intervention Description
2-3 instructed meditation sessions per week in addition to standard medical care.
Intervention Type
Other
Intervention Name(s)
Standard Medical Care
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
Primary Outcome Measure Information:
Title
Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
Time Frame
3 month interval
Title
Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
Time Frame
3 month intervals
Title
Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.
Time Frame
3 month intervals
Title
Increase in heart rate variability for patients participating in vipassana meditation training.
Time Frame
3 month intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 to 85 All patients with NYHA class II to III congestive heart failure symptoms from ischemic and non-ischemic etiology who received a defibrillator at least 3 months prior to enrollment. All patients with NYHA class III and IV symptoms, QRS complex of the ECG more than 120 ms, who received device for cardiac resynchronization at least 3 months prior to enrollment. These devices are placed when the two ventricles beat at slightly different times. These devices also have the capacity to record arrhythmias as the defibrillators. Exclusion Criteria: Patients with life expectancy less than 6 months from non-cardiac causes Pregnant women Smokers History of major psychosis. Significant chronic liver, renal and pulmonary disease Active alcohol and drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Srivatsa, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdmc.ucdavis.edu/clinicaltrials/trialDetail.aspx?protocol=200715089
Description
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Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation

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