NCT00611260

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:

  1. 1.Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
  2. 2.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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

January 25, 2008

Last Update Submit

May 25, 2017

Conditions

Congestive Heart FailureCardiac Resynchronization Therapy

Keywords

MeditationCongestive Heart FailureICDCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (4)

  • Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.

    3 month interval

  • Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.

    3 month intervals

  • Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.

    3 month intervals

  • Increase in heart rate variability for patients participating in vipassana meditation training.

    3 month intervals

Study Arms (2)

Meditation Cohort

EXPERIMENTAL

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.

Behavioral: Vipassana Meditation practice and instruction

Standard Care

ACTIVE COMPARATOR

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

Other: Standard Medical Care

Interventions

Vipassana Meditation practice and instructionBEHAVIORAL

2-3 instructed meditation sessions per week in addition to standard medical care.

Also known as: Meditation + ICD
Meditation Cohort
Standard Medical CareOTHER

Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.

Also known as: Standard of Care
Standard Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Educational StatusMeditationStandard of Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Uma Srivatsa, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 8, 2008

Study Start

April 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)