Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure

NCT04549701 | Completed DMC

• 1 other identifier: 090920
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 congestion to guide treatment.

Conditions

Heart Failure; Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• Subclinical congestion at discharge

  Discharge

Secondary Outcomes (1)

• Readmission for heart failure, unplanned visit for worsening HF, or death.

  90 days

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

CAVAL US-guided Therapy OTHER

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.

CAVAL US group

Standard of care OTHER

Standard of care will be provided.

CAVAL US group; Standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Instituto Cardiovascular de Buenos Aires: lead

Study Sites (2)

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires City, 1428, Argentina

Location

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1428, Argentina

Location

Related Publications (1)

• 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.

  PMID: 36344108 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: CAVAL US will be performed on all patients, and patients will be blinded to the assigned group. The treating medical team will be blind to the CAVAL US results of the control group. Independent clinicians adjudicating 90-day events will not participate in patient follow-up, and will be blind to the assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: March 20, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 28, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

AR (2)