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

Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?

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).

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Behavioral: Vipassana Meditation practice and instruction; Other: Standard Medical 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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Vipassana Meditation practice and instruction; 2-3 instructed meditation sessions per week in addition to standard medical care.; Other Names: Meditation + ICD
Active Comparator: Standard Care; 25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.	Other: Standard Medical Care; Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Uma Srivatsa, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Meditation; ICD; Cardiac Resynchronization Therapy; Congestive Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 200715089