Expired Study
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Sacramento, California 95817


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).


Study summary:

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.


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


Study is Available At:


Original ID:

200715089


NCT ID:

NCT00611260


Secondary ID:


Study Acronym:


Brief Title:

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?


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Uma Srivatsa, MD
Principal Investigator
University of California, Davis

Study Dates

Start Date:April 2007
Completion Date:February 2012
Completion Type:Actual
Primary Completion Date:February 2012
Primary Completion Type:Actual
Verification Date:March 2013
Last Changed Date:March 26, 2013
First Received Date:January 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Increase in heart rate variability for patients participating in vipassana meditation training.
Time Frame:3 month intervals
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
Time Frame:3 month intervals
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
Time Frame:3 month interval
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Vipassana Meditation practice and instruction
Description:2-3 instructed meditation sessions per week in addition to standard medical care.
Arm Name:Meditation Cohort
Other Name:Meditation + ICD
Intervention Type:Other
Name:Standard Medical Care
Description:Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
Arm Name:Standard Care
Other Name:Standard of Care

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard Care
Description:25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.
Study Arm Type:Experimental
Arm Name:Meditation Cohort
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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