Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death

Completed

• Conditions: Menopausal Women

• Registration Number: NCT00580775
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-27
• Primary Completion: 2008-07
• Study Completion: 2010-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180

Exclusion Criteria

• non-participants of parent study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability	48 Months

Secondary Outcome Measures

Name	Time	Method
Repolarization parameters	48 Months

Trial Locations

Locations (1)

Yale University School of Medicine / Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States