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Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAVAL US group | Experimental | Patients assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to the treating medical team, in addition to standard care. Diuretic titration: There will not be a specific treatment protocol, but clinicians will be encouraged to tailor treatment, particularly with the use of diuretics, according to the number of B-lines and dilation in the IVC. The therapeutic objective will be discharge patients normal CAVAL US, with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory alterations that contraindicate discharge. |
|
| Standard of care group | Active Comparator | Patients assigned to this group will receive standard care, and diuretic titration will be based on standard practice (physical examination, symptoms, and laboratory results). The therapeutic objective will be discharge patients with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory abnormalities that contraindicate discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAVAL US-guided Therapy | Other | Patients randomly assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to treating medical team, in addition to the standard care. |
| Measure | Description | Time Frame |
|---|---|---|
| Subclinical congestion at discharge | Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission for heart failure, unplanned visit for worsening HF, or death. | Readmission for heart failure: unscheduled urgent hospital visit and stay longer than 24 hours, requiring medical interventions. Mortality: death of the patient. Unplanned visit for worsening heart failure: unscheduled visit to the emergency department that led to an increase in oral / intravenous therapy, stay less than 24 hours. |
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Inclusion Criteria:
- Hospitalization of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to FC III-IV, bendopnea or fatigue) or signs of volume overload.
and - Jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion.
and
and
- Sufficient ultrasound visualization to assess IVC and lungs.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Cardiovascular de Buenos Aires | Buenos Aires | Buenos Aires City | 1428 | Argentina | ||
| Instituto Cardiovascular de Buenos Aires |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36344108 | Derived | Burgos LM, Baro Vila R, Goyeneche A, Munoz F, Spaccavento A, Fasan MA, Ballari F, Vivas M, Riznyk L, Ghibaudo S, Trivi M, Ronderos R, Costabel JP, Botto F, Diez M; CAVAL US-AHF group. Design and rationale of the inferior vena CAVA and Lung UltraSound-guided therapy in Acute Heart Failure (CAVAL US-AHF Study): a randomised controlled trial. Open Heart. 2022 Nov;9(2):e002105. doi: 10.1136/openhrt-2022-002105. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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CAVAL US will be performed on all patients, and patients will be blinded to the assigned group.
The treating medical team will be blind to the CAVAL US results of the control group.
Independent clinicians adjudicating 90-day events will not participate in patient follow-up, and will be blind to the assigned group.
| Standard of care | Other | Standard of care will be provided. |
|
| 90 days |
| Buenos Aires |
| Buenos Aires F.D. |
| 1428 |
| Argentina |