Clinical trial NCT00611260: Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
Official title: Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Cardiac Resynchronization Therapy
Keywords: Meditation
Congestive Heart Failure
ICD
Cardiac Resynchronization Therapy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
timeFrame: 3 month interval
measure: Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
timeFrame: 3 month intervals
measure: Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.
timeFrame: 3 month intervals
measure: Increase in heart rate variability for patients participating in vipassana meditation training.
timeFrame: 3 month intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Uma Srivatsa, MD
role: PRINCIPAL_INVESTIGATOR
References: