Menopause Racing Heart Study

Menopause Related Conditions Clinical Trial

Official title:

Menopause Racing Heart Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05062057
• Other study ID #: 12409
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: February 16, 2024

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 62 Years

Eligibility

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)

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

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

Locations

Country	Name	City	State
United States	Indiana CTSI Clinical Research Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Moment-to-moment self-report of palpitations events recorded through an event marker button		28 days
Secondary	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