Congestive Heart FailureNCT00611260
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
A study testing Vipassana Meditation practice and instruction and Standard Medical Care in people with Congestive Heart Failure and Cardiac Resynchronization Therapy, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- Vipassana Meditation practice and instruction and Standard Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
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:
- Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
- 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).
Read the 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.
- Being tested
- Vipassana Meditation practice and instruction, Standard Medical Care
- Keywords
- Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vipassana Meditation practice and instructionBehavioural
Also called Meditation + ICD
2-3 instructed meditation sessions per week in addition to standard medical care.
Standard Medical CareOther
Also called Standard of Care
Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Cohort | Experimental | 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. Receives: Behavioral: Vipassana Meditation practice and instruction |
| Standard Care | Active comparator | 25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health. Receives: Other: Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
Measured: 3 month interval
Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
Measured: 3 month intervals
Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.
Measured: 3 month intervals
Increase in heart rate variability for patients participating in vipassana meditation training.
Measured: 3 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uma Srivatsa, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611260
- Sponsor's protocol ID
- 200715089
- Status last verified
- May 2017
- First submitted
- 25 Jan 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
- ClinicalTrials.gov ID
- NCT00611260
- Acronym / sponsor ID
- 200715089
- Keywords
- Meditation, Congestive Heart Failure, ICD, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Cohort | Experimental | Behavioral: Vipassana Meditation practice and instruction25 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. |
| Standard Care | Active comparator | Other: Standard Medical Care25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vipassana Meditation practice and instructionAlso: Meditation + ICD2-3 instructed meditation sessions per week in addition to standard medical care. | Behavioural | Meditation Cohort |
| Standard Medical CareAlso: Standard of CareStandard medical care for patients with congestive heart failure plus implanted cardiac defibrillators. | Other | Standard Care |
Primary outcome
Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.
Time frame: 3 month interval
Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.
Time frame: 3 month intervals
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
Increase in heart rate variability for patients participating in vipassana meditation training.
Time frame: 3 month intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma Srivatsa, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vipassana Meditation practice and instruction and Standard Medical Care in people with Congestive Heart Failure and Cardiac Resynchronization Therapy, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. (time frame: 3 month interval). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.