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

NCT ID: NCT04549701

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2023-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CAVAL US group

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.

Group Type: EXPERIMENTAL

CAVAL US-guided Therapy

Intervention Type: 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.

Standard of care

Intervention Type: OTHER

Standard of care will be provided.

Standard of care group

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.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care will be provided.

Interventions

CAVAL US-guided Therapy

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.

Intervention Type: OTHER

Standard of care

Standard of care will be provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Cardiovascular de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Lucrecia Maria Burgos

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires City, Argentina

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 36344108 (View on PubMed)

Other Identifiers

090920

Identifier Type: -

Identifier Source: org_study_id