Heart FailureCAVA-ADHFNCT03140566
Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF
A study testing Ultrasound evaluation of the inferior vena cava diameter in people with Heart Failure, run by University of Luebeck at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ultrasound evaluation of the inferior vena cava diameter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2017to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Heart Failure
- Being tested
- Ultrasound evaluation of the inferior vena cava diameter, Sham ultrasound evaluation of the inferior vena cava diameter
- Keywords
- heart failure, acute decompensated heart failure, congestion, inferior vena cava
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluation of the inferior vena cava diameterDiagnostic test
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.
Sham ultrasound evaluation of the inferior vena cava diameterDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical assessment plus IVC diameter | Experimental | Decongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter Receives: Diagnostic Test: Ultrasound evaluation of the inferior vena cava diameter |
| Clinical assessment only | Sham comparator | Decongesting treatment guided by clinical assessment alone Receives: Diagnostic Test: Sham ultrasound evaluation of the inferior vena cava diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
Proportion of patients with per-protocol treatment in the experimental group.
Measured: 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
Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess vital status (all-cause mortality). In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted.
Measured: 180 days after randomization
Cardiovascular mortality
Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess vital status (all-cause mortality). In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted. Medical reports will be requested to adjudicate cause of death.
Measured: 180 days after randomization
Unscheduled readmission for any cause
Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess readmission status. In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted.
Measured: 180 days after randomization
Readmission for heart failure
Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess readmission status. In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted. Medical reports will be requested to adjudicate cause of readmission.
Measured: 180 days after randomization
Hemoconcentration
Hemoconcentration will be defined as a relative increase in hemoglobin from baseline to discharge.
Measured: 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)
Freedom from signs of congestion at discharge
Freedom from signs of congestion at discharge is defined as the absence of orthopnea, pulmonary rales, and jugular venous distension in conjunction with none or only a trace of edema at discharge.
Measured: 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)
Cumulative loop diuretic dose during index hospitalization
For calculation of the cumulative loop diuretic dose during index hospitalization all intrahospital applied doses of loop diuretics will be converted to intravenous furosemide equivalents and summed up. Preclinical doses applied by the emergency medical services will not be considered.
Measured: 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)
Length of index hospitalization
Time in days from hospital admission to hospital dicharge.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start3 Jun 2017
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Holger Thiele, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140566
- Sponsor's protocol ID
- CAVA-ADHF-DZHK10
- Acronym
- CAVA-ADHF
- Status last verified
- Jul 2017
- First submitted
- 25 Apr 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40929999
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03140566
- Acronym / sponsor ID
- CAVA-ADHF / CAVA-ADHF-DZHK10
- Conditions
- Heart Failure
- Keywords
- heart failure, acute decompensated heart failure, congestion, inferior vena cava
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical assessment plus IVC diameter | Experimental | Diagnostic Test: Ultrasound evaluation of the inferior vena cava diameterDecongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter |
| Clinical assessment only | Sham comparator | Diagnostic Test: Sham ultrasound evaluation of the inferior vena cava diameterDecongesting treatment guided by clinical assessment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound evaluation of the inferior vena cava diameterTreatment 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. | Diagnostic test | Clinical assessment plus IVC diameter |
| Sham ultrasound evaluation of the inferior vena cava diameterTeatment 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. | Diagnostic test | Clinical assessment only |
Primary outcome
Change in NT-proBNP from baseline to discharge
Time frame: 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)
The core laboratory at Luebeck will determine NT-proBNP levels for calculation of the endpoint from samples obtained at baseline and at discharge.
9 secondary outcomes
Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients
Time frame: 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
Time frame: 180 days after randomization
Cardiovascular mortality
Time frame: 180 days after randomization
Unscheduled readmission for any cause
Time frame: 180 days after randomization
Readmission for heart failure
Time frame: 180 days after randomization
Hemoconcentration
Time frame: 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)
Freedom from signs of congestion at discharge
Time frame: 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)
Cumulative loop diuretic dose during index hospitalization
Time frame: 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)
Length of index hospitalization
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 40929999Jobs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound evaluation of the inferior vena cava diameter in people with Heart Failure, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP from baseline to discharge (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.