Clinical trial NCT05373732: Stress Reduction in the Prevention of Left Ventricular Hypertrophy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Hypertrophy
High Blood Pressure
Keywords: left ventricular mass
meditation
stress reduction
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Charles Drew University of Medicine and Science
First posted: 2022-05-13
Enrollment: 171
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

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Primary outcomes:
measure: left ventricular mass (LVM)
timeFrame: 6 months pre to post
Secondary outcomes:
measure: blood pressure
timeFrame: 0 and 6 months
measure: anger expression
timeFrame: 0 and 6 months
measure: perceived stress
timeFrame: 0 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi International University
name: Robert H Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.