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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00580775

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

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)

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Observing heart rate variability in placebo and active estrogen preparations
Active estogen Observing heart rate variability in placebo and active estrogen preparations

Outcome Measures

Primary Outcome Measures

Heart rate variability [48 Months]

Secondary Outcome Measures

Repolarization parameters [48 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Years to 58 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

non-participants of parent study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine / Yale New Haven Hospital	New Haven	Connecticut	United States	208017

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Rachel Lampert, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rachel Lampert, Associate Professor of Medicine, Yale University

ClinicalTrials.gov Identifier:

NCT00580775

Other Study ID Numbers:

0505000069

First Posted:

Dec 27, 2007

Last Update Posted:

Jan 22, 2015

Last Verified:

Jan 1, 2015

Keywords provided by Rachel Lampert, Associate Professor of Medicine, Yale University

Menopause

Hormone Replacement Therapy

Sudden Cardiac Death

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Jan 22, 2015