Clinical trial NCT00420108: Optivol Diagnostic Data for Discharge in Heart Failure
Official title: Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Cardiac Pacemaker, Artificial
Keywords: Heart Failure, Congestive
Cardiac Pacemaker, Artificial
Ventricular Pressure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-01-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.

Brief summary: The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

Detailed description: Implantable cardioverter defibrillator (ICD) devices with or without cardiac resynchronization therapy (CRT-D) have the ability to continuously monitor heart rate variability, daily heart rate, and patient activity. Changes in these measures have been associated with heart failure prognosis. In addition, ICD or CRT-D devices also have the ability to measure daily intrathoracic impedance. Previous data have demonstrated that device-based intrathoracic impedance measurements correlate with pulmonary capillary wedge pressure and fluid retention, both of which are common measures of heart failure status. The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance can be used in conjunction with other methods to determine if patients are ready for hospital discharge. This will be the first step in potentially developing an inpatient care strategy which includes implantable device data. It is hypothesized that device diagnostic data will identify an appropriate and safe time to discharge patients admitted for worsening heart failure symptoms before usual clinical indicators. More specifically, we hypothesize that device data will "normalize" at least one day prior to the clinical indicators of readiness for discharge and patients discharged prior to "normalization" of the device data will be at greater risk for rehospitalization

Eligibility criteria: Inclusion Criteria:

* Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for \>30 days.
* Anticipated hospitalization stay \>48 hours
* Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

Exclusion Criteria:

* Anemia - admission hemoglobin \<8.0 g/dL
* Patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Joseph
country: United States
facility: Heartland Health
state: Missouri
city: Elmer
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Lankenau Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David J Whellan, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: