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

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ClinicalTrials.gov Identifier: NCT00611260
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Cardiac Resynchronization Therapy Behavioral: Vipassana Meditation practice and instruction Other: Standard Medical Care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : April 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 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




Primary Outcome Measures :
  1. Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. [ Time Frame: 3 month interval ]
  2. Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. [ Time Frame: 3 month intervals ]
  3. 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 ]
  4. Increase in heart rate variability for patients participating in vipassana meditation training. [ Time Frame: 3 month intervals ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00611260     History of Changes
Other Study ID Numbers: 200715089
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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