Acute Heart Failure, Heart Failure
Conditions
Brief summary
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.
Interventions
OTHERCAVAL US-guided Therapy
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.
OTHERStandard of care
Standard of care will be provided.
Sponsors
Instituto Cardiovascular de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Chest X-ray with signs suggestive of pulmonary congestion. and * Elevated ´pro-B-type natriuretic peptide (NT-proBNP) levels of 450 pg/mL, 900 pg/mL, and 1800 pg/mL for ages \< 50 years, 50 to 75 years, and \> 75 years, respectively, within 24 hours of admission (53,54). and \- Sufficient ultrasound visualization to assess IVC and lungs.
Exclusion criteria
* Not willing to participate. * Life expectancy of less than 6 months. * Uninterpretable lung or inferior vena cava ultrasound. * Transfer to another hospital before hospital discharge. * SBP \< 90 mm Hg. * Chronic kidney disease (creatinine clearance \<30 mL/min calculated with the MDRD equation or hemodialysis). * Requirement for invasive or noninvasive ventilator support. * Pregnancy. * Low cardiac output syndrome/cardiogenic shock. * Death during index hospitalization. * Acute coronary syndrome, myocardial revascularization or heart valve replacement within the previous 3 months. * Being on heart transplant waiting list. * Cardiac resynchronization therapy device implanted within the previous 3 months. * Severe tricuspid valve regurgitation. * Heart failure secondary to causes amenable to invasive correction: cardiac surgery, percutaneous interventions or pacemaker implantation. * Heart failure secondary to significant arrhythmias (advanced atrioventricular block or sinus arrest, sustained ventricular tachycardia or any sustained arrhythmia other than atrial fibrillation causing hemodynamic instability according to the discretion of the treating physician). * Heart failure secondary to severe systemic infection * Severe psychiatric illness * Palliative care * SARS-CoV-2 infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subclinical congestion at discharge | Discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission for heart failure, unplanned visit for worsening HF, or death. | 90 days | 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. |
Countries
Argentina
Outcome results
None listed