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

University of California (UC) Davis

Status: Completed

Conditions: Cardiac Resynchronization Therapy; Congestive Heart Failure

Treatments: Other: Standard Medical Care; Behavioral: Vipassana Meditation practice and instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT00611260

200715089

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Meditation Cohort

Experimental group

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.

Treatment:

Behavioral: Vipassana Meditation practice and instruction

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Medical Care