Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD (CHARM COPD)

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: VitalPatch

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05290831

1653926

Details and patient eligibility

About

The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.

Full description

The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.

Enrollment: 45 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent

2. At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC < 0.7 and FEV1 < 80% predicted)

3. 10 pack year smoking history

4. Hospitalized with one or more of:

   1. increased dyspnea
   2. increased sputum
   3. change in sputum character

5. Treated with corticosteroids and/or antibiotics for respiratory indications

6. Age > 40 years old

Exclusion criteria

1. Discharging home on hospice
2. Inability to follow trial protocols
3. Pacemaker
4. Allergy to a component of the adhesive patches
5. Breastfeeding
6. Permanent/continuous atrial fibrillation

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Main study group

Experimental group

Treatment:

Device: VitalPatch