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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611260
• Other study ID #: 200715089
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: May 25, 2017
• Start date: April 2007
• Est. completion date: February 2012

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Congestive Heart Failure
• Heart Failure

Intervention

Behavioral:
• Vipassana Meditation practice and instruction
2-3 instructed meditation sessions per week in addition to standard medical care.

Other:
• Standard Medical Care
Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.		3 month interval
Primary	Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.		3 month intervals
Primary	Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.		3 month intervals
Primary	Increase in heart rate variability for patients participating in vipassana meditation training.		3 month intervals