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Left Ventricular HypertrophyNCT05373732

Stress Reduction in the Prevention of Left Ventricular Hypertrophy

A study testing meditation in people with Left Ventricular Hypertrophy and High Blood Pressure, run by Maharishi International University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive African-American adults over a six-month intervention period. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
No sites listed yet
Study dates
Apr 1996to Dec 1998
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: self-identified African-American men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (SBP) of 120-139 mm Hg and/or diastolic blood pressure (DBP) of 80-89 mm Hg), Stage-1 hypertension (SBP of 140-159 mm Hg and/or DBP of 90-99 mm Hg) or Stage-2 hypertension (SBP of 160-179 and/or DBP of 100-109 mm of Hg), with or without antihypertensive medications -

Exclusion Criteria: Patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ECG abnormalities, major psychiatric or behavioral disorder such as alcoholism (> 28 drinks per week)

-

About this study

Official title: Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans

This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive African-American adults over a six-month intervention period.

Read the detailed description

Left ventricular hypertrophy (LVH) is an independent risk factor for cardiovascular disease (CVD). African Americans have higher rates of LVH and CVD than whites. Substantial evidence indicates that psychological stress contributes to LVH. This randomized controlled trial evaluated the effect of stress reduction with the Transcendental Meditation (TM) technique on left ventricular mass (LVM) in hypertensive African-Americans.

Hypertensive African American men and women were tested at baseline for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, lifestyle and behavioral factors. Subjects were randomly assigned to either TM or health education (HE) control. After six months intervention, 86 subjects were posttested on all outcomes. Data were analyzed for between-group and within-group differences.

Being tested
meditation, Health education control
Keywords
left ventricular mass, meditation, stress reduction
Medical subject headings
Hypertrophy, Left Ventricular, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • meditationBehavioural

    Also called stress reduction

    meditation practice 20 minutes twice a day at home and attending classes at the clinic.

  • Health education controlBehavioural

    didactic based classes in CVD risk factor reduction and prevention

Study groups in NCT05373732
Study groupRoleWhat they receive
Transcendental MeditationExperimentalThe Transcendental Meditation (TM) technique is described as a simple, natural technique that is practiced twice a day for 20 minutes while sitting comfortably with eyes closed. There are no required changes in lifestyle, beliefs or philosophy. Instruction in the TM technique involves a seven-step course over five sessions (90-minute meetings).
Receives: Behavioral: meditation
Health EducationActive comparatorThe health education (HE) intervention provided behavioral instructions for CVD risk factor prevention . This group received written materials, structured presentations, didactic instructions and group support for modifying the major cardiovascular risk factors including salt restriction, weight reduction, aerobic exercise, alcohol and smoking cessation.
Receives: Behavioral: Health education control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. left ventricular mass (LVM)

    The primary outcome was change in LVMI. LVM was measured by M-mode echocardiography and indexed by body surface area to generate LVMI. [18] Measurements were obtained at the end-diastole. Interventricular septal thickness, posterior wall thickness, and left ventricle internal dimension were measured.

    Measured: 6 months pre to post

Secondary outcomes (3)

  1. blood pressure

    systolic and diastolic blood pressure

    Measured: 0 and 6 months

  2. anger expression

    Speilberger Anger expression scale

    Measured: 0 and 6 months

  3. perceived stress

    Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale

    Measured: 0 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study startApr 1996
  3. Primary completionOct 1998
  4. Study completionDec 1998

Resources

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
Model description
A randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-Americans
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05373732
Sponsor's protocol ID
2100mdmvc
Status last verified
May 2022
First submitted
6 Apr 2022
Last updated
13 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD is available on request to authors from other study investigators. Database on Excel is available to be emailed to inquiring investigators

Publications

  • Schneider RH, Myers HF, Marwaha K, Rainforth MA, Salerno JW, Nidich SI, Gaylord-King C, Alexander CN, Norris KC. Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans. Ethn Dis. 2019 Oct 17;29(4):577-586. doi: 10.18865/ed.29.4.577. eCollection 2019 Fall.

    PubMed 31641325

Questions about this trial

What is this clinical trial studying?

A study testing meditation in people with Left Ventricular Hypertrophy and High Blood Pressure, run by Maharishi International University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

left ventricular mass (LVM) (time frame: 6 months pre to post). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05373732, which also lists 1 linked publication.

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 13 May 2022.

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