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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uma Srivatsa, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00611260
First received: January 25, 2008
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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).

Condition Intervention
Congestive Heart Failure
Cardiac Resynchronization Therapy
Behavioral: Vipassana Meditation practice and instruction
Other: Standard Medical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. [ Time Frame: 3 month interval ] [ Designated as safety issue: No ]
  • Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Increase in heart rate variability for patients participating in vipassana meditation training. [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Standard of 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611260

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Uma Srivatsa, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Uma Srivatsa, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00611260     History of Changes
Other Study ID Numbers: 200715089
Study First Received: January 25, 2008
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Meditation
Congestive Heart Failure
ICD
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014