Optivol Diagnostic Data for Discharge in Heart Failure (3DHF)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Heart Failure, Congestive; Cardiac Pacemaker, Artificial

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

Study Design

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Study Type :	Observational
Actual Enrollment :	23 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness
Study Start Date :	December 2006
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   None Retained

No biospecimens to be retained

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Missouri
Heartland Health
St. Joseph, Missouri, United States, 64506
United States, New Jersey
Cardiovascular Associates of Delaware Valley
Elmer, New Jersey, United States, 083618
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Temple University
Philadelphia, Pennsylvania, United States, 19140
Main Line Health Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096

Sponsors and Collaborators

Thomas Jefferson University

Medtronic

Investigators

Principal Investigator:	David J Whellan, MD MHS	Thomas Jefferson University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Office of Research Administration, Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00420108 History of Changes
Other Study ID Numbers:	06U.232
First Posted:	January 9, 2007
Last Update Posted:	August 20, 2010
Last Verified:	August 2010

Keywords provided by Thomas Jefferson University:

Heart Failure, Congestive; Cardiac Pacemaker, Artificial; Ventricular Pressure

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases