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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00580775
First received: December 19, 2007
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Menopausal Women

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: 48 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repolarization parameters [ Time Frame: 48 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Placebo
Observing heart rate variability in placebo and active estrogen preparations
Active estogen
Observing heart rate variability in placebo and active estrogen preparations

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.

  Eligibility

Ages Eligible for Study:   42 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • non-participants of parent study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580775

Locations
United States, Connecticut
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
  More Information

No publications provided

Responsible Party: Rachel Lampert, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00580775     History of Changes
Other Study ID Numbers: 0505000069
Study First Received: December 19, 2007
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Menopause
Hormone Replacement Therapy
Sudden Cardiac Death

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
 Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013