Menopausal WomenKEEPSNCT00580775
Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death
An observational study of Menopausal Women, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.
Who may be able to join
- participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180
Who cannot join
- non-participants of parent study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine / Yale New Haven Hospital
New Haven, Connecticut, 208017
About this study
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)
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.
Read the 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.
- Conditions
- Menopausal Women
- Keywords
- Menopause, Hormone Replacement Therapy, Sudden Cardiac Death
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: 48 Months
Secondary outcomes (1)
Repolarization parameters
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startSep 2005
- Primary completionJul 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Lampert, Yale University
- Investigators
- Rachel Lampert, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580775
- Sponsor's protocol ID
- 0505000069
- Acronym
- KEEPS
- Status last verified
- Jan 2015
- First submitted
- 19 Dec 2007
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00580775
- Acronym / sponsor ID
- KEEPS / 0505000069
- Conditions
- Menopausal Women
- Keywords
- Menopause, Hormone Replacement Therapy, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | –Observing heart rate variability in placebo and active estrogen preparations |
| Active estogen | – | –Observing heart rate variability in placebo and active estrogen preparations |
Who may qualify
- Ages
- 42 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.
Key inclusion criteria (1 listed)
- participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180
Key exclusion criteria (1 listed)
- non-participants of parent study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate variability
Time frame: 48 Months
1 secondary outcome
Repolarization parameters
Time frame: 48 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
Related trials for Menopausal Women
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Recruiting
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
Glucose Monitoring, Continuous, Whole Body Protein Metabolism
Active, not recruitingPhase 2
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Estrogen Receptor Positive Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Lampert, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Women, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 48 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.