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The purpose of the study is to determine if there is a reduction in the length of stay and rates of rehospitalization for patients diagnosed with congestive heart failure when physicians are provided daily measurements of peripheral venous pressure versus no daily measurements of peripheral venous pressure.
The objective of the study is to evaluate the effectiveness of standard clinical care versus standard clinical care directed by peripheral venous pressure on length of hospital stay and incidence of rehospitalization among heart failure patients.
The study team hypothesizes that compared to standard clinical care the peripheral venous pressure-guided therapy is associated with shorter hospital stay and lesser incidence of 30-day rehospitalization. The study team will also collect data to determine if peripheral venous pressure-guided care is associated with reduced incidence of 6-month rehospitalization, improvement in symptoms or lab indices, lesser new incidence of dialysis, change in use of diuretics, and lesser use of echocardiograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peripheral venous pressure measurements | Experimental | Peripheral venous pressure measures provided to physicians daily up to 8 days |
|
| standard clinical care | Active Comparator | Usual standard clinical care, peripheral venous pressure measures not provided to physician daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral venous pressure measurements | Other | Peripheral venous pressure measures provided to physicians daily up to 8 days, with a research note in the electronic medical record containing standardized recommendations for case also provided daily. Care changes up to clinical provider discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Number of days from admission to discharge | up to day 8 |
| Number of subjects rehospitalized | Number of subjects in each group who have been rehospitalized | Day 30 post index hospitalization |
| Number of subjects rehospitalized | Number of subjects in each group who have been rehospitalized | Month 6 post index hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with exertional dyspnea | Number of subjects in each group experiencing dyspnea according to the New York Heart Association Class | Day 1 and date of discharge (up to day 8) |
| Number of subjects with exertional orthopnea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khawaja Ammar, MD | Contact | (414) 649-6181 | Khawaja.Ammar@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Khawaja Ammar, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| standard clinical care | Other | Usual standard clinical care |
|
Number of subjects in each group experiencing orthopnea according to the New York Heart Association Class
| Day 1 and date of discharge (up to day 8) |
| Number of subjects with new need for dialysis during index hospitalization | Number of subjects in each group with new need for dialysis during index hospitalization | Day 1 and date of discharge (up to day 8) |
| Number of subjects with diuretic use | Number of subjects in each group with diuretic use during index hospitalization | Day 1 and date of discharge (up to day 8) |
| Number of subjects with echocardiograms | Number of subjects in each group with echocardiograms performed (with results) during index hospitalization | Day 1 and date of discharge (up to day 8) |
| Number of subjects with all-cause death | Number of subjects in each group with all-cause death | Month 6 post index hospitalization |
| Number of subjects with cardiac-related death | Number of subjects in each group with cardiac-related death | Month 6 post index hospitalization |