Abstract
Background: Residual congestion at hospital discharge after an episode of acute decompensated heart failure (ADHF) is associated with poor prognosis. There is no consensus on how optimal decongestion should be assessed. Objectives: This study aims to determine whether decongestive therapy guided by ultrasound measurements of inferior vena cava (IVC) diameters leads to greater reductions in N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels from baseline to hospital discharge as compared with decongestion treatment guided by clinical assessment alone. Methods: In a randomized controlled multicenter trial, patients admitted for ADHF (NYHA functional class ≥III) exhibiting signs of pulmonary congestion, peripheral edema, and NT-proBNP levels >300 ng/L were randomized to either decongestion therapy guided by daily IVC ultrasound plus clinical assessment or clinical assessment alone. The primary endpoint was the change in NT-proBNP levels from baseline to discharge. Results: A total of 388 patients were randomized, of which 327 were included in the primary intention-to-treat analysis. The between-group difference in primary endpoint of change in NT-proBNP levels was 5.4% (95% CI: −9.4% to 22.6%; P = 0.58). Safety events were numerically less frequent in the IVC ultrasound–guided group. No difference between groups was consistently observed in secondary endpoints with similar rates of hemoconcentration and intensity of diuretic treatment. Conclusions: Additional ultrasound evaluation of IVC diameters did not improve decongestion treatment compared with clinical assessment alone among patients admitted for ADHF. (Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF [CAVA-ADHF-DZHK10]; NCT03140566).
| Originalsprache | Englisch |
|---|---|
| Aufsatznummer | 102578 |
| Zeitschrift | JACC: Heart Failure |
| Jahrgang | 13 |
| Ausgabenummer | 10 |
| ISSN | 2213-1779 |
| DOIs | |
| Publikationsstatus | Veröffentlicht - 10.2025 |
Fördermittel
The CAVA-ADHF trial was planned and conducted as an investigator-initiated, randomized, controlled, patient-blinded, multicenter, parallel-group trial without industry involvement. Details regarding the rationale and design have been published previously. 14 The trial protocol is available with the full text of this paper ( Supplemental Appendix: Study Protocol ) and was approved by the local ethics committees of each participating center. All patients provided written informed consent before any trial-specific procedure. The trial was fully funded by the DZHK (German Center for Cardiovascular Research). A data and safety monitoring board reviewed all safety aspects of the trial. A.J. designed the trial and drafted the trial protocol, which was modified during the review process, in accordance with feedback from the steering committee and experts at the DZHK. The trial design was finally approved by the steering committee. A.J. drafted the manuscript and all authors jointly decided to submit it for publication after review. As part of the sponsor's data confidentiality requirements, all trial site investigators, including the authors, signed confidentiality agreements. The steering committee and trial statistician, respectively, vouch for the accuracy and completeness of the data, and the precision of the data analysis in adherence to the trial protocol.
| Träger | Trägernummer |
|---|---|
| Deutsches Zentrum für Herz-Kreislaufforschung |
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