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

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Congestive Heart Failure
• Interventions: Behavioral: Vipassana Meditation practice and instruction; Other: Standard Medical Care

• Registration Number: NCT00611260
• Lead Sponsor: University of California, Davis

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. 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).

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-08
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation Cohort	Vipassana Meditation practice and instruction	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.
Standard Care	Standard Medical Care	25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States