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

University of California, Davis27 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure Cardiac Resynchronization Therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 month interval

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

Time frame: 3 month intervals

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

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

Time frame: 3 month intervals

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes