Clinical trial NCT03140566: Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF
Official title: Ultrasound Evaluation of the Inferior Vena Cava in Addition to Clinical Assessment to Guide Decongestion in Acute Decompensated Heart Failure: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
acute decompensated heart failure
congestion
inferior vena cava
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2017-05-04
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in NT-proBNP from baseline to discharge
timeFrame: Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
Secondary outcomes:
measure: Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients
timeFrame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
measure: All-cause mortality
timeFrame: 180 days after randomization
measure: Cardiovascular mortality
timeFrame: 180 days after randomization
measure: Unscheduled readmission for any cause
timeFrame: 180 days after randomization
measure: Readmission for heart failure
timeFrame: 180 days after randomization
measure: Hemoconcentration
timeFrame: Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
measure: Freedom from signs of congestion at discharge
timeFrame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
measure: Cumulative loop diuretic dose during index hospitalization
timeFrame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
measure: Length of index hospitalization
timeFrame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck
Study officials:
References: