View Clinical Trial (Medical Research Study)
Mechanisms of the Relaxation Response in Elderly Hypertensives
| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55410 |
| Conditions: |
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Hypertension |
| Purpose: |
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Systolic Hypertension is a disorder which is characterized by significant elevations in
systolic blood pressure in association with normal diastolic blood pressure. Typically,
this develops in individuals >50 years of age and is associated with an increased risk of
stroke and myocardial infarction. While there are many effective therapies for
essential/diastolic hypertension, the treatment of systolic hypertension is complicated by
side effects from traditional therapies. This limits therapeutic options and has resulted
in a number of at-risk individuals being left untreated.
We are conducting a randomized, controlled trial (n=90) to compare the effects of two
different stress management training on blood pressure. The primary outcome is change in
systolic blood pressure and pulse pressure. Secondary outcomes are changes in nitric oxide,
stress hormones and psychological well-being. Additional analyses will be conducted to
assess for other confounding effects on BP and PP.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Male or female; stage I SH (140-159 mm Hg SBP and < 90 mm Hg DBP), > 55 years of age;
taking at least 1 anti-hypertensive medication at a stable dose for 1 month preceding
the screening visit; understanding of English; normal hearing; and able to provide
informed consent.
Exclusion Criteria:
- Presence of current neurological, psychiatric, medical or musculoskeletal disorder;
current asthma; severe seasonal allergies resulting in screening NO values > 60 ppb;
current smoking; experience with yoga, meditation, guided imagery or other techniques
that evoke the RR; hematocrit below 32; glucose lower than 50 or higher than 200; a
creatinine greater than 1.3, Mini-Mental Status Exam score less than 26 or clinical
depression based on a score of greater than 15 on the CES-D and Health Counselor's
clinical evaluation. Subjects can not take the following medications: beta-agonist
bronchodilators, systemic corticosteroids, anti-convulsants, immunosuppressive or
cytotoxic therapy (currently or within the last 12 months), anabolic steroids,
anti-depressants (not including SSRIs), anti-psychotics, chronic sypathomimetic
medications, and dicyclomine.
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| NCT ID: |
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NCT00913991 |
| Primary Contact: |
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Principal Investigator
Jeffery Dusek, PhD
Abbott Northwestern Hospital
Amber Fyfe-Johnson, ND
Phone: 612/863-9865
Email: amber.fyfe-johnson@allina.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Minneapolis, Minnesota 55410
United States
Jeffery Dusek, PhD
Phone: 612-863-6105
Email: jeffery.dusek@allina.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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