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

NCT ID: NCT00580775

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Menopausal Women

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Placebo

Observing heart rate variability in placebo and active estrogen preparations

No interventions assigned to this group

Active estogen

Observing heart rate variability in placebo and active estrogen preparations

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• non-participants of parent study

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Lampert

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Lampert, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine / Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0505000069

Identifier Type: -

Identifier Source: org_study_id