Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure

Heart Failure Clinical Trial

— CAVAL US-AHF  

Official title:

Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549701
• Other study ID #: 090920
• Status: Completed
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2024
• Source: Instituto Cardiovascular de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• CAVAL 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.
• Standard of care
Standard of care will be provided.

Locations

Country	Name	City	State
Argentina	Instituto Cardiovascular de Buenos Aires	Buenos Aires	Buenos Aires City
Argentina	Instituto Cardiovascular de Buenos Aires	Buenos Aires	Ciudad Autónoma De Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Cardiovascular de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subclinical congestion at discharge		Discharge
Secondary	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.	90 days