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

Effects of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death: Autonomic Function and Ventricular Repolarization Heterogeneity ( A KEEPS Ancillary Study)

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.

Study Overview

• Status: Completed
• Conditions: Menopausal Women

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 208017
      • Yale University School of Medicine / Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 58 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• non-participants of parent study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Placebo; Observing heart rate variability in placebo and active estrogen preparations
Active estogen; Observing heart rate variability in placebo and active estrogen preparations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart rate variability	48 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Repolarization parameters	48 Months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Rachel Lampert, M.D., Yale University

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (ESTIMATE): December 27, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Menopause; Sudden Cardiac Death; Hormone Replacement Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: 0505000069