Congestive Heart Failure(CHF) Clinical Trial
Official title:
KYMA Device: External Measure of Thoracic Fluid and Vital Signs
External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients.
This is a prospective, single center, non-randomized study designed to correlate Kyma
measurements and in-hospital parameters as well as the changes in TFC and vital signs with
clinical changes in the outpatient setting for 60 days post-discharge. The patient and
hospital study personnel will be blinded to the Kyma data captured by the device. No
intervention will be performed on the patient based on the Kyma device data, this is an
observational study.
The goals of the study are:
1. Follow thoracic fluid and vital signs in acute, hospitalized heart failure(HF) patients
with evidence of volume overload to evaluate this combined parameter in relation to
decongestion (time to clear lung auscultation or clearing of congestion on chest x-ray
or decrease in BNP by 50%), clinical symptoms, physical exam, and biomarker results.
2. Evaluate the relationship between lung decongestion as externally measured and
hemodynamic parameters as measured by pulmonary artery catheter in a subset of patients
3. Correlate changes in thoracic fluid content and vital signs with clinical changes in the
outpatient setting for 60 days post-discharge.
4. Evaluate the feasibility of implementing a physician-directed, patient- managed model of
diuretic and vasodilator adjustment.
Patients will be approached for enrollment within 24 hours of presentation to the hospital.
The Kyma device will be applied to the patient. Data will be automatically collected by the
device: TFC will be measured every 30 minutes and vital signs will be measured several times
an hour.
Information collected at baseline by the study coordinators will include medications, lab
work (CBC, Chemistry, BNP), ejection fraction(EF), weight, vital signs, and lung auscultation
for both Cohorts.
Cohorts I and II may be enrolled concurrently. For patients enrolled in Cohort I, PA readings
will be recorded at baseline and 3 times daily until the pulmonary artery(PA) catheter is
removed.
While hospitalized, all patients will have daily weights, intake/output, Physical
Exams(edema, jugular venous distention(JVP), lung exam) and vital signs will be recorded
twice daily. Lab results will be recorded as well as any changes in medication.
After hospital discharge, the patients will wear the Kyma device for an additional 60 days.
Patients will be contacted by telephone at 10 days, 30 days, and 60 days post-discharge for
weight measurements, medication changes, and assessment of any Office Visits, or
ER/Hospitalizations for SOB.
The Minnesota Living with Heart Failure Questionnaire will be administered at hospital
discharge and 30 and 60 days post-discharge.
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