Skip to main content
OpenTrials
Completed

NCT Number: NCT00580775

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menopausal Women Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

42 year–58 year

Sex eligibility

Female

Study type

Observational

Primary location

Yale University School of Medicine / Yale New Haven Hospital

New Haven, Connecticut, 208017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • non-participants of parent study

Treatment and study plan

Primary outcomes

  1. Heart rate variability

    Time frame: 48 Months

Secondary outcomes

  1. Repolarization parameters

    Time frame: 48 Months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: KEEPS

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Dec 27, 2007
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.