Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | December 2015 |
| Contact: | David Majure, MD |
| Email: | David.T.Majure@medstar.net |
| Phone: | 202-877-8085 |
Characterizing Noninvasive Cardiovascular Measures Collected Passively and In Response to an Isometric Handgrip Stress Test From CVInsight®, Connex ProBP, and Zio® XT Patch in Patients With Acute Decompensated Heart Failure
HF001 is a prospective observational study utilizing non-invasive medical devices that may
be able to discriminate changes in heart failure while acutely decompensated patients
undergo routine interventional therapies in a hospital setting. Subjects will be monitored
using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric
handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to
standard assessments of heart failure including pulmonary artery catheter (PAC) pressures,
blood pressure (BP), patient symptoms, and physical exam findings. The results of this study
will be used to develop a powered study to determine if a new configuration of non-invasive
monitoring devices can be used to monitor heart failure status more sensitively than current
non-invasive techniques.
be able to discriminate changes in heart failure while acutely decompensated patients
undergo routine interventional therapies in a hospital setting. Subjects will be monitored
using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric
handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to
standard assessments of heart failure including pulmonary artery catheter (PAC) pressures,
blood pressure (BP), patient symptoms, and physical exam findings. The results of this study
will be used to develop a powered study to determine if a new configuration of non-invasive
monitoring devices can be used to monitor heart failure status more sensitively than current
non-invasive techniques.
Inclusion Criteria:
- Adult patients ≥ 18 years old
- Signs and symptoms of congestive heart failure including two of the following:
- Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in
the setting of elevated jugular venous pressure as assessed by the clinical
examination, or by right heart catheterization.
- Pulmonary edema or pleural effusion as seen on chest X-ray
- Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of
normal.
- Willing and able to comply with the study protocol
- Willing and able to give valid Informed Consent
Exclusion Criteria:
- Pregnant patients
- Presence of Left Ventricular Assist Device (LVAD) or heart transplant
- Complex congenital heart disorder or prosthetic valve on right side
- Known mitral stenosis
- Unstable medical condition or impairment other than condition associated with HF
- Unstable hypertension
- Too unstable in the judgment of the investigator to be included in the study
- Active lung infection or acute pulmonary decompensation
- Elevated white blood cell count and signs of infection are evident
- Does not have the cognitive ability to understand and sign the Informed Consent
- Does not have the cognitive capacity to perform handgrip test
- Is not able to perform a handgrip stress test
- Is not able to wear any of the devices
- Patient's life expectancy is less than 3 months
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