|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00580775 |
Purpose
As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.
| Condition |
|---|
|
Menopausal Women |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Effects of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death: Autonomic Function and Ventricular Repolarization Heterogeneity ( A KEEPS Ancillary Study) |
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Placebo
Observing heart rate variability in placebo and active estrogen preparations
|
|
Active estogen
Observing heart rate variability in placebo and active estrogen preparations
|
The parent study KEEPS, will be a randomized, placebo-controlled double blinded, prospective trial with two active groups and one placebo group. Only patients enrolled in KEEPS will be invited to participate in this ancillary study.Duration of the KEEPS study will be for 4 years after randomization for each study subject, with assessment of the primary endpoint, carotid CIMT, twice at baseline, 12, 24, 36 and 48 months. Ancillary to the KEEPS study, patients will undergo holter monitoring at baseline, 24 and 48 months.Data will be analyzed after 24 and 48 months (corresponding to data analysis of the primary endpoints.) Holter monitors will be put on during the scheduled KEEPS visits, will be worn for 24 hours and will be returned the following day. Effects of estrogen on heart rate variability (HRV) and repolarization parameters will be evaluated, and also correlated with clinical, quality of life, sleep and mood information gathered through the parent study. Anticipated enrollment from the parent study at this site is 90 study subjects. This ancillary does not involve the use of drugs or investigational devices.
Eligibility| Ages Eligible for Study: | 42 Years to 58 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine / Yale New Haven Hospital | |
| New Haven, Connecticut, United States, 208017 | |
| Principal Investigator: | Rachel Lampert, M.D. | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Rachel Lampert, M.D. ) |
| Study ID Numbers: | 0505000069 |
| Study First Received: | December 19, 2007 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00580775 |
| Health Authority: | United States: Institutional Review Board |
|
Menopause Hormone Replacement Therapy Sudden Cardiac Death |
|
Death Heart Diseases Death, Sudden |
Heart Arrest Death, Sudden, Cardiac Menopause |
|
Pathologic Processes Cardiovascular Diseases |
