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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Congestive Heart Failure Cardiac Resynchronization Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meditation Cohort

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.

Group Type EXPERIMENTAL

Vipassana Meditation practice and instruction

Intervention Type BEHAVIORAL

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

Standard Care

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

Group Type ACTIVE_COMPARATOR

Standard Medical Care

Intervention Type OTHER

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

Interventions

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Vipassana Meditation practice and instruction

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

Intervention Type BEHAVIORAL

Standard Medical Care

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

Intervention Type OTHER

Other Intervention Names

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Meditation + ICD Standard of Care

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No