Menopause Related ConditionsNCT05062057
Menopause Racing Heart Study
An observational study of Menopause Related Conditions, run by Indiana University at 1 site in United States.
Trial summary
Palpitations occur in more than 25% of women as they approach menopause and after menopause. However, the etiology of menopausal palpitations has not been studied, and it is unknown whether palpitations in menopausal women are caused by underlying arrhythmias or other electrocardiographic (ECG) abnormalities. Read more about this study
- Who is it for?
- Ages 40 to 62 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Adhesive ambulatory ECG recording patches
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 16 Feb 2024
- 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 40 to 62 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Peri- and postmenopausal women between the ages of 40 and 62 years who: 1) Self-report palpitations within the previous 2 weeks prior to enrollment (Palpitations group) and 2) Have no self-reported palpitations within 6 months prior to enrollment (Control group)
Who may be able to join
- Women aged 40-62 years
- Upper limit of 62 years because this is 10 years past the median age at menopause, which is the age range when most women experience menopause symptoms
- Peri-menopausal women
- Defined as no menses in the past 3 months or menses in the past 3 months but cycles are less regular (as self-reported by the women)20
- Postmenopausal women
- No menses for 12 months or longer
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- Women with surgical menopause will be included
- Willing to wear the adhesive heart monitor on their chest for 28 days
- Palpitations group: women who have reported palpitations within the previous 2 weeks
- Control group: Women who report having no palpitations within the past 6 months
- Completion of 2-week symptom diary
Who cannot join
- Pregnant
- Breastfeeding
- History of arrhythmias (with the exception of sinus bradycardia, sinus arrhythmia or sinus tachycardia)
- History of stroke
- History of heart failure
- Permanent pacemaker
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- Taking antiarrhythmic drugs (with the exception of ß-blockers, diltiazem or verapamil)
- Known skin allergies (CAM patches are contraindicated)
- Family history of skin allergies (CAM patches are contraindicated)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46202
About this study
Palpitations occur in more than 25% of women as they approach menopause and after menopause. However, the etiology of menopausal palpitations has not been studied, and it is unknown whether palpitations in menopausal women are caused by underlying arrhythmias or other electrocardiographic (ECG) abnormalities.
Objective:
Read more
- The primary objective of this exploratory pilot study is to assess whether arrhythmias and/or other ECG abnormalities underlie symptomatic palpitations in peri- and postmenopausal women 2 The secondary objective is to better understand women's palpitations symptom experiences (describe the symptom, its dimensions (frequency, severity, distress, duration, temporal pattern, aggravating/alleviating factors), and any attempted or actual healthcare utilization related to the symptom (provider contacts, discussions, referrals; laboratory or other tests).
In this study, 30 peri- and post-menopausal women will be enrolled to determine if they have underlying arrhythmias or other ECG abnormalities. n=15 peri/postmenopausal women who describe palpitations within the previous 2 weeks and a control group of n=15 peri/postmenopausal women who have not experienced palpitations within 6 months will be enrolled. All participants will undergo placement of a 14-day adhesive ECG monitoring patch [(Carnation Ambulatory Monitoring (CAM) patch, Bardy Diagnostics] on their chest. After wearing the patch for 14 days, the patch will be removed, and a 2nd 14-day patch will be placed, for a total of 28 days of ECG recording. Data from the adhesive ECG patches will be uploaded and an assessment of arrhythmias and other ECG changes will be made. In addition, all participants will undergo a semi-structured interview to obtain information on their palpitations symptoms experience.
Changes in study procedure:
- To reduce participant and staff burden and costs, in April 2023, we reduced the ECG wear time to 14 days and eliminated study visit 3. We did this because the ECH patches did not always adhere well to the skin, necessitating extra study visits, extra patches, and additional costs.
- Because of the COVID-19 pandemic delays in study initiation and the ECG issues, we recruited 15 rather than the originally planned 20 women in each group. The new sample size was consistent with our limited funding, limited staff resources, and the pilot nature of the study.
- Conditions
- Menopause Related Conditions
- Being tested
- Adhesive ambulatory ECG recording patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive ambulatory ECG recording patchesDevice
All women in both groups will undergo sequential placement of two 14-day adhesive ambulatory ECG recording patches for a total of 28 days of ECG recording
| Study group | Role | What they receive |
|---|---|---|
| Palpitations | n=15 peri- and postmenopausal women with self-reported palpitations within 2 weeks prior to enrollment Receives: Device: Adhesive ambulatory ECG recording patches | |
| No palpitations | n=15 peri- and postmenopausal women with no self-reported palpitations within 6 months prior to enrollment Receives: Device: Adhesive ambulatory ECG recording patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmias
Incidence and nature of arrhythmias in peri- and postmenopausal women who report symptomatic palpitations. Arrhythmias to be assessed include, but are not limited to:
- Accelerated idioventricular rhythm
- AF
- Atrial flutter
- Atrial tachycardia
- Atrioventricular blocks (2nd and 3rd degree)
- Junctional rhythm
- Junctional tachycardia
- Premature atrial complexes (PACs)
- PVCs, including couplets, bigeminy, trigeminy
- Sinus tachycardia
- Supraventricular tachycardia (AV nodal reentrant tachycardia, AV reentrant tachycardia)
- Ventricular tachycardia (monomorphic and polymorphic)
- Any other abnormal rhythms discovered
Measured: 28 days
Secondary outcomes (2)
Moment-to-moment self-report of palpitations events recorded through an event marker button
Measured: 28 days
Narrative descriptions of women's symptom experiences
Symptom dimensions (e.g., frequency, severity, temporal pattern) and treatment-seeking (e.g., reports to healthcare professionals, tests, ER visits)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start6 Jan 2022
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Responsible party
- Principal investigator, James E. Tisdale, Indiana University
- Investigators
- James E Tisdale, PharmD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062057
- Sponsor's protocol ID
- 12409
- Status last verified
- Feb 2025
- First submitted
- 13 Sep 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified subject data will be shared with other investigators upon request
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause Racing Heart Study
- ClinicalTrials.gov ID
- NCT05062057
- Acronym / sponsor ID
- 12409
- Conditions
- Menopause Related Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 30 Sep 2021 (actual)
- 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.
Palpitations occur in more than 25% of women as they approach menopause and after menopause. However, the etiology of menopausal palpitations has not been studied, and it is unknown whether palpitations in menopausal women are caused by underlying arrhythmias or other electrocardiographic (ECG) abnormalities.
Objective:
- The primary objective of this exploratory pilot study is to assess whether arrhythmias and/or other ECG abnormalities underlie symptomatic palpitations in peri- and postmenopausal women 2 The secondary objective is to better understand women's palpitations symptom experiences (describe the symptom, its dimensions (frequency, severity, distress, duration, temporal pattern, aggravating/alleviating factors), and any attempted or actual healthcare utilization related to the symptom (provider contacts, discussions, referrals; laboratory or other tests).
In this study, 30 peri- and post-menopausal women will be enrolled to determine if they have underlying arrhythmias or other ECG abnormalities. n=15 peri/postmenopausal women who describe palpitations within the previous 2 weeks and a control group of n=15 peri/postmenopausal women who have not experienced palpitations within 6 months will be enrolled. All participants will undergo placement of a 14-day adhesive ECG monitoring patch [(Carnation Ambulatory Monitoring (CAM) patch, Bardy Diagnostics] on their chest. After wearing the patch for 14 days, the patch will be removed, and a 2nd 14-day patch will be placed, for a total of 28 days of ECG recording. Data from the adhesive ECG patches will be uploaded and an assessment of arrhythmias and other ECG changes will be made. In addition, all participants will undergo a semi-structured interview to obtain information on their palpitations symptoms experience.
Changes in study procedure:
- To reduce participant and staff burden and costs, in April 2023, we reduced the ECG wear time to 14 days and eliminated study visit 3. We did this because the ECH patches did not always adhere well to the skin, necessitating extra study visits, extra patches, and additional costs.
- Because of the COVID-19 pandemic delays in study initiation and the ECG issues, we recruited 15 rather than the originally planned 20 women in each group. The new sample size was consistent with our limited funding, limited staff resources, and the pilot nature of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpitations | – | Device: Adhesive ambulatory ECG recording patchesn=15 peri- and postmenopausal women with self-reported palpitations within 2 weeks prior to enrollment |
| No palpitations | – | Device: Adhesive ambulatory ECG recording patchesn=15 peri- and postmenopausal women with no self-reported palpitations within 6 months prior to enrollment |
Who may qualify
- Ages
- 40 to 62 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Peri- and postmenopausal women between the ages of 40 and 62 years who: 1) Self-report palpitations within the previous 2 weeks prior to enrollment (Palpitations group) and 2) Have no self-reported palpitations within 6 months prior to enrollment (Control group)
Key inclusion criteria (11 listed)
- Women aged 40-62 years
- Upper limit of 62 years because this is 10 years past the median age at menopause, which is the age range when most women experience menopause symptoms
- Peri-menopausal women
- Postmenopausal women
- Women with surgical menopause will be included
Key exclusion criteria (9 listed)
- Pregnant
- Breastfeeding
- History of arrhythmias (with the exception of sinus bradycardia, sinus arrhythmia or sinus tachycardia)
- History of stroke
- History of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesive ambulatory ECG recording patchesAll women in both groups will undergo sequential placement of two 14-day adhesive ambulatory ECG recording patches for a total of 28 days of ECG recording | Device | No palpitations, Palpitations |
Primary outcome
Arrhythmias
Time frame: 28 days
Incidence and nature of arrhythmias in peri- and postmenopausal women who report symptomatic palpitations. Arrhythmias to be assessed include, but are not limited to: * Accelerated idioventricular rhythm * AF * Atrial flutter * Atrial tachycardia * Atrioventricular blocks (2nd and 3rd degree) * Junctional rhythm * Junctional tachycardia * Premature atrial complexes (PACs) * PVCs, including couplets, bigeminy, trigeminy * Sinus tachycardia * Supraventricular tachycardia (AV nodal reentrant tachycardia, AV reentrant tachycardia) * Ventricular tachycardia (monomorphic and polymorphic) * Any other abnormal rhythms discovered
2 secondary outcomes
Moment-to-moment self-report of palpitations events recorded through an event marker button
Time frame: 28 days
Narrative descriptions of women's symptom experiences
Time frame: 28 days
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 14 Feb 2025.
- Individual participant dataSharing planned: Undecided. De-identified subject data will be shared with other investigators upon request
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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.
James E Tisdale, PharmD principal investigator
Purdue 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 Menopause Related Conditions, run by Indiana 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 11 inclusion and 9 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 14 Feb 2025. 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?
Arrhythmias (time frame: 28 days). 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 14 Feb 2025.