Menopause Racing Heart Study

What this trial studies

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).

Conditions in scope

• Menopause Related Conditions

Interventions

• Adhesive ambulatory ECG recording patches (Device) — 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

Who can join

Women only · Ages 40 Years to 62 Years · Accepts healthy volunteers.

Inclusion criteria

• 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
• Women with surgical menopause will be included
• Willing to wear the adhesive heart monitor on their chest for 28 days

Exclusion criteria

• 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
• Taking antiarrhythmic drugs (with the exception of ß-blockers, diltiazem or verapamil)
• Known skin allergies (CAM patches are contraindicated)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2022-01-06
• Primary completion: 2024-02-16
• Last update posted: 2025-02-14
• First posted: 2021-09-30

Sponsor & contact

Lead sponsor: Indiana University (Other)

Collaborators: Indiana Clinical and Translational Sciences Institute

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Arrhythmias (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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.