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Completed

NCT Number: NCT00611260

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

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).

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Key information

Conditions

Congestive Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vipassana Meditation practice and instruction

Behavioral

2-3 instructed meditation sessions per week in addition to standard medical care.

Other names: Meditation + ICD

Standard Medical Care

Other

Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.

Other names: Standard of Care

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2008
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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