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

Menopausal Women Clinical Trial

— KEEPS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580775
• Other study ID #: 0505000069
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: January 20, 2015
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: January 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 58 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• non-participants of parent study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Menopausal Women

Locations

Country	Name	City	State
United States	Yale University School of Medicine / Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability		48 Months	No
Secondary	Repolarization parameters		48 Months	No