Optivol Diagnostic Data for Discharge in Heart Failure (3DHF)
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| ClinicalTrials.gov Identifier: NCT00420108 |
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Recruitment Status :
Completed
First Posted : January 9, 2007
Last Update Posted : August 20, 2010
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Sponsor:
Thomas Jefferson University
Collaborator:
Medtronic
Information provided by:
Thomas Jefferson University
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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 |
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| Heart Failure, Congestive Cardiac Pacemaker, Artificial |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
Biospecimen Retention: None Retained
No biospecimens to be retained
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420108
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 |
| Responsible Party: | Office of Research Administration, Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00420108 |
| Other Study ID Numbers: |
06U.232 |
| First Posted: | January 9, 2007 Key Record Dates |
| Last Update Posted: | August 20, 2010 |
| Last Verified: | August 2010 |
Keywords provided by Thomas Jefferson University:
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Heart Failure, Congestive Cardiac Pacemaker, Artificial Ventricular Pressure |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |