Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF
CAVA-ADHF
1 other identifier
interventional
388
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
June 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2019
CompletedSeptember 25, 2019
July 1, 2017
2.3 years
April 25, 2017
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NT-proBNP from baseline to discharge
The core laboratory at Luebeck will determine NT-proBNP levels for calculation of the endpoint from samples obtained at baseline and at discharge.
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 (9)
Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients
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)
All-cause mortality
180 days after randomization
Cardiovascular mortality
180 days after randomization
Unscheduled readmission for any cause
180 days after randomization
Readmission for heart failure
180 days after randomization
- +4 more secondary outcomes
Study Arms (2)
Clinical assessment plus IVC diameter
EXPERIMENTALDecongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter
Clinical assessment only
SHAM COMPARATORDecongesting treatment guided by clinical assessment alone
Interventions
Treatment will be guided by clinical assessment and ultrasound evaluation of the inferior vena cava (IVC) diameter. Decongestion should lead to maximal IVC diameter ≤2.1 cm and IVC collapsibility index \>50% in addition to relief of symptoms and signs of congestion before discharge.
Teatment guided by clinical assessment alone. Decongestion should lead to relief of symptoms and signs of congestion before discharge. IVC ultrasound evaluation is performed, but results are not reported to treating physicians.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitäres Herzzentrum Lübeck
Lübeck, 23538, Germany
Related Publications (1)
Jobs A, Rausch TK, Konig IR, Vonthein R, Devendra A, Schafer J, Nauck M, Eitel I, Stiermaier T, Laugwitz KL, Ledwoch J, Valentova M, von Haehling S, Stork S, Arnold N, Karakas M, Westermann D, Lenz T, Gori T, Edelmann F, Seppelt P, Felix SB, Lutz M, Hedwig F, Akin I, Scherer C, Desch S, Thiele H; CAVA-ADHF-DZHK10 Investigators. Inferior Vena Cava Ultrasound to Guide Decongestion in Acute Decompensated Heart Failure: A Randomized Controlled Trial. JACC Heart Fail. 2025 Oct;13(10):102578. doi: 10.1016/j.jchf.2025.102578. Epub 2025 Sep 9.
PMID: 40929999DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 25, 2017
First Posted
May 4, 2017
Study Start
June 3, 2017
Primary Completion
September 24, 2019
Study Completion
September 24, 2019
Last Updated
September 25, 2019
Record last verified: 2017-07