Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICENon-invasive hemodynamic monitoring (CVInsight™ [CVI])
Sponsors
Intelomed, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure | Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation |
Countries
United States
Outcome results
None listed