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To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).
To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function
This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.
There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFrEF | Participants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction. |
| |
| HFpEF | Participants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable cardiac monitor | Device | Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Signal Detection | Characterize differences in cardiac physiology and dynamics between heart failure with preserved ejection fraction and heart failure with reduced ejection fraction patient populations using a wearable cardiac monitor prototype device. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Lam, MD | National Heart Center Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| National Heart Center Singapore |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Singapore |
| 169609 |
| Singapore |
| MacKay Memorial Hospital | Taipei | 10449 | Taiwan |