Heart FailureCAVAL US-AHFNCT04549701
Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure
A study testing CAVAL US-guided Therapy in people with Heart Failure and Acute Heart Failure, run by Instituto Cardiovascular de Buenos Aires at 2 sites in Argentina.
Trial summary
Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- CAVAL US-guided Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesArgentina
- Study dates
- 20 Mar 2022to 28 Feb 2023
- 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 of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to FC III-IV, bendopnea or fatigue) or signs of volume overload.
- and - Jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion.
- and
- Chest X-ray with signs suggestive of pulmonary congestion. and
- Elevated ´pro-B-type natriuretic peptide (NT-proBNP) levels of 450 pg/mL, 900 pg/mL, and 1800 pg/mL for ages < 50 years, 50 to 75 years, and > 75 years, respectively, within 24 hours of admission (53,54).
- and
- Sufficient ultrasound visualization to assess IVC and lungs.
Who cannot join
- Not willing to participate.
- Life expectancy of less than 6 months.
- Uninterpretable lung or inferior vena cava ultrasound.
- Transfer to another hospital before hospital discharge.
- SBP < 90 mm Hg.
- Chronic kidney disease (creatinine clearance <30 mL/min calculated with the MDRD equation or hemodialysis).
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- Requirement for invasive or noninvasive ventilator support.
- Pregnancy.
- Low cardiac output syndrome/cardiogenic shock.
- Death during index hospitalization.
- Acute coronary syndrome, myocardial revascularization or heart valve replacement within the previous 3 months.
- Being on heart transplant waiting list.
- Cardiac resynchronization therapy device implanted within the previous 3 months.
- Severe tricuspid valve regurgitation.
- Heart failure secondary to causes amenable to invasive correction: cardiac surgery, percutaneous interventions or pacemaker implantation.
- Heart failure secondary to significant arrhythmias (advanced atrioventricular block or sinus arrest, sustained ventricular tachycardia or any sustained arrhythmia other than atrial fibrillation causing hemodynamic instability according to the discretion of the treating physician).
- Heart failure secondary to severe systemic infection
- Severe psychiatric illness
- Palliative care
- SARS-CoV-2 infection
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Instituto Cardiovascular de Buenos Aires
Buenos Aires, Buenos Aires City, 1428
Instituto Cardiovascular de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1428
About this study
Official title: Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)
Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.
- Conditions
- Heart Failure, Acute Heart Failure
- Being tested
- CAVAL US-guided Therapy, Standard of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVAL US-guided TherapyOther
Patients randomly assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to treating medical team, in addition to the standard care.
Standard of careOther
Standard of care will be provided.
| Study group | Role | What they receive |
|---|---|---|
| CAVAL US group | Experimental | Patients assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to the treating medical team, in addition to standard care. Diuretic titration: There will not be a specific treatment protocol, but clinicians will be encouraged to tailor treatment, particularly with the use of diuretics, according to the number of B-lines and dilation in the IVC. The therapeutic objective will be discharge patients normal CAVAL US, with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory alterations that contraindicate discharge. Receives: Other: CAVAL US-guided Therapy; Other: Standard of care |
| Standard of care group | Active comparator | Patients assigned to this group will receive standard care, and diuretic titration will be based on standard practice (physical examination, symptoms, and laboratory results). The therapeutic objective will be discharge patients with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory abnormalities that contraindicate discharge. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical congestion at discharge
Measured: Discharge
Secondary outcomes (1)
Readmission for heart failure, unplanned visit for worsening HF, or death.
Readmission for heart failure: unscheduled urgent hospital visit and stay longer than 24 hours, requiring medical interventions.
Mortality: death of the patient. Unplanned visit for worsening heart failure: unscheduled visit to the emergency department that led to an increase in oral / intravenous therapy, stay less than 24 hours.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start20 Mar 2022
- Primary completion31 Jan 2023
- Study completion28 Feb 2023
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Cardiovascular de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549701
- Sponsor's protocol ID
- 090920
- Acronym
- CAVAL US-AHF
- Status last verified
- May 2024
- First submitted
- 9 Sep 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Burgos LM, Baro Vila R, Goyeneche A, Munoz F, Spaccavento A, Fasan MA, Ballari F, Vivas M, Riznyk L, Ghibaudo S, Trivi M, Ronderos R, Costabel JP, Botto F, Diez M; CAVAL US-AHF group. Design and rationale of the inferior vena CAVA and Lung UltraSound-guided therapy in Acute Heart Failure (CAVAL US-AHF Study): a randomised controlled trial. Open Heart. 2022 Nov;9(2):e002105. doi: 10.1136/openhrt-2022-002105.
PubMed 36344108
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)
- ClinicalTrials.gov ID
- NCT04549701
- Acronym / sponsor ID
- CAVAL US-AHF / 090920
- Conditions
- Heart Failure, Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto Cardiovascular de Buenos AiresUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Sep 2020 (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.
Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAVAL US group | Experimental | Other: CAVAL US-guided Therapy, Other: Standard of carePatients assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to the treating medical team, in addition to standard care. Diuretic titration: There will not be a specific treatment protocol, but clinicians will be encouraged to tailor treatment, particularly with the use of diuretics, according to the number of B-lines and dilation in the IVC. The therapeutic objective will be discharge patients normal CAVAL US, with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory alterations that contraindicate discharge. |
| Standard of care group | Active comparator | Other: Standard of carePatients assigned to this group will receive standard care, and diuretic titration will be based on standard practice (physical examination, symptoms, and laboratory results). The therapeutic objective will be discharge patients with relief of congestive signs and symptoms of HF, without electrocardiographic or laboratory abnormalities that contraindicate discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalization of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to FC III-IV, bendopnea or fatigue) or signs of volume overload.
- and - Jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion.
- and
- Chest X-ray with signs suggestive of pulmonary congestion. and
- Elevated ´pro-B-type natriuretic peptide (NT-proBNP) levels of 450 pg/mL, 900 pg/mL, and 1800 pg/mL for ages < 50 years, 50 to 75 years, and > 75 years, respectively, within 24 hours of admission (53,54).
Key exclusion criteria (20 listed)
- Not willing to participate.
- Life expectancy of less than 6 months.
- Uninterpretable lung or inferior vena cava ultrasound.
- Transfer to another hospital before hospital discharge.
- SBP < 90 mm Hg.
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 |
|---|---|---|
| CAVAL US-guided TherapyPatients randomly assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to treating medical team, in addition to the standard care. | Other | CAVAL US group |
| Standard of careStandard of care will be provided. | Other | CAVAL US group, Standard of care group |
Primary outcome
Subclinical congestion at discharge
Time frame: Discharge
1 secondary outcome
Readmission for heart failure, unplanned visit for worsening HF, or death.
Time frame: 90 days
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 4 Jun 2024.
- Derived from this study: PubMed 36344108Burgos LM, Baro Vila R, Goyeneche A, Munoz F, Spaccavento A, Fasan MA, Ballari F, Vivas M, Riznyk L, Ghibaudo S, Trivi M, Ronderos R, Costabel JP, Botto F, Diez M; CAVAL US-AHF group. Design and rationale of the inferior vena CAVA and Lung UltraSound-guided therapy in Acute Heart Failure (CAVAL US-AHF Study): a randomised controlled trial. Open Heart. 2022 Nov;9(2):e002105. doi: 10.1136/openhrt-2022-002105.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAVAL US-guided Therapy in people with Heart Failure and Acute Heart Failure, run by Instituto Cardiovascular de Buenos Aires at 2 sites in Argentina.
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 7 inclusion and 20 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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. 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?
Subclinical congestion at discharge (time frame: Discharge). 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 NCT04549701, 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 4 Jun 2024.