Menopause Racing Heart 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:

1. 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, 40 peri- and post-menopausal women will be enrolled to determine if they have underlying arrhythmias or other ECG abnormalities. n=20 peri/postmenopausal women who describe palpitations within the previous 2 weeks and a control group of n=20 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.

Study Overview

• Status: Recruiting
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Device: Adhesive ambulatory ECG recording patches

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Janet S Carpenter, PhD; Phone Number: 317-278-6093; Email: carpentj@iu.edu
• Study Contact Backup: Name: James E Tisdale, PharmD; Phone Number: 317-880-5418; Email: jtisdale@purdue.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana CTSI Clinical Research Center
      • Contact: Laurie Trevino; Phone Number: 317-274-0952; Email: lhackwar@iupui.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

1. Women aged 40-62 years
2. 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

3. 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

4. Postmenopausal women

   • No menses for 12 months or longer
5. Women with surgical menopause will be included
6. Willing to wear the adhesive heart monitor on their chest for 28 days
7. Palpitations group: women who have reported palpitations within the previous 2 weeks
8. Control group: Women who report having no palpitations within the past 6 months
9. Completion of 2-week symptom diary

Exclusion Criteria:

1. Pregnant
2. Breastfeeding
3. History of arrhythmias (with the exception of sinus bradycardia, sinus arrhythmia or sinus tachycardia)
4. History of stroke
5. History of heart failure
6. Permanent pacemaker
7. Taking antiarrhythmic drugs (with the exception of ß-blockers, diltiazem or verapamil)
8. Known skin allergies (CAM patches are contraindicated)
9. Family history of skin allergies (CAM patches are contraindicated)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Palpitations; n=20 peri- and postmenopausal women with self-reported palpitations within 2 weeks prior to enrollment	Device: Adhesive ambulatory ECG recording patches; 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
No palpitations; n=20 peri- and postmenopausal women with no self-reported palpitations within 6 months prior to enrollment	Device: Adhesive ambulatory ECG recording patches; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moment-to-moment self-report of palpitations events recorded through an event marker button		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)	28 days

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana Clinical and Translational Sciences Institute
• Investigators: Principal Investigator: James E Tisdale, PharmD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 12409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified subject data will be shared with other investigators upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No