Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF (CAVA-ADHF)

University of Luebeck

Status

Completed

Conditions

Heart Failure

Treatments

Diagnostic Test: Ultrasound evaluation of the inferior vena cava diameter

Diagnostic Test: Sham ultrasound evaluation of the inferior vena cava diameter

Study type

Interventional

Funder types

Other

Identifiers

NCT03140566

CAVA-ADHF-DZHK10

Details and patient eligibility

About

CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial. The objective is to test whether evaluation of the inferior vena cava diameter in addition to clinical assessment is superior compared to clinical assessment alone with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Full description

Only limited evidence is available on the best method to monitor and guide decongestion in acute decompensated heart failure. Therefore, no specific guideline recommendations are made in this regard. It is unknown whether an objective congestion marker can be used to guide decongestion or such marker is only of prognostic value by identifying high-risk patients with an advanced disease state.

CAVA-ADHF is designed as prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial and aims to demonstrate effectiveness of inferior vena cava (IVC)-guided decongestion, its feasibility, and to estimate effect size and variability of clinical endpoints following the intention-to-treat principle.

After inclusion and exclusion criteria have been checked patients will be randomized:

Experimental intervention: Decongesting treatment guided by clinical assessment and ultrasound evaluation of the IVC diameter. Decongestion should lead to a maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.

Control intervention: Decongesting treatment guided by clinical assessment alone. The IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Trial intervention will end with discharge from the index hospitalization. Patients will be followed-up for 180 to 210 days after randomization.

The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Enrollment

388 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hospitalization for ADHF with dyspnea ≥NYHA III, peripheral edema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph)
Age ≥18 years
NT-proBNP >300 ng/l within 24 h after admission
Sufficient ultrasound visualization to evaluate IVC
IVCmax >2.1 cm and IVCCI ≤50 % in the baseline assessment within 24 h after admission
Capability to sign informed consent personally

Exclusion criteria

Cardiogenic shock with systolic blood pressure <90 mmHg plus end-organ hypoperfusion
ADHF due to significant arrhythmias
Severe pulmonary disease as primary cause of dyspnea
Simplified Modification of Diet in Renal Disease estimated glomerular filtration rate <30 ml/min/1.73 m²
Need for non-invasive or invasive ventilation support at baseline
Pregnancy
Participation in another interventional trial regarding heart failure treatment