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

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ClinicalTrials.gov Identifier: NCT00580775
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Rachel Lampert, Yale University

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
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
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 : September 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 48 Months ]

Secondary Outcome Measures :
  1. Repolarization parameters [ Time Frame: 48 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 58 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rachel Lampert, Associate Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT00580775     History of Changes
Other Study ID Numbers: 0505000069
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

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

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