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

BACKGROUND: Between 25% and 30% of patients hospitalised 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. OBJECTIVE: To evaluate if inferior vena cava (IVC) and lung ultrasound (CAVAL US)-guided therapy for AHF patients reduces subclinical congestion at discharge. METHODS: CAVAL US-AHF is a single-centre, single-blind randomised controlled trial designed to evaluate if an IVC and lung ultrasound-guided healthcare strategy is superior to standard care to reduce subclinical congestion at discharge. Fifty-eight patients with AHF will be randomised using a block randomisation programme that will assign to either lung and IVC ultrasound-guided decongestion therapy (‘intervention group’) or clinical-guided decongestion therapy (‘control group’), using a quantitative protocol and will be classified in three groups according to the level of congestion observed: none or mild, moderate or severe. The treating physicians will know the result of the test and the subsequent adjustment of treatment in response to those findings guided by a customised therapeutic algorithm. The primary endpoint is the presence of more than five B-lines and/or an increase in the diameter of the IVC, with and without collapsibility. The secondary endpoints are the composite of readmission for HF, unplanned visit for worsening HF or death at 90 days, variation of pro-B-type natriuretic peptide at discharge, length of hospital stay and diuretic dose at 90 days. Analyses will be conducted as between-group by intention to treat. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board and registered in the PRIISA.BA platform of the Ministry of Health of the City of Buenos Aires. TRIAL REGISTRATION NUMBER: NCT04549701.