Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure (CAVAL US-AHF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Heart Failure
• Intervention / Treatment: Other: CAVAL US-guided Therapy; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires City
    • Buenos Aires, Buenos Aires City, Argentina, 1428
      • Instituto Cardiovascular de Buenos Aires
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1428
      • Instituto Cardiovascular de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other: Standard of care; Standard of care will be provided.
Active Comparator: 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.	Other: Standard of care; Standard of care will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subclinical congestion at discharge	Discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Collaborators and Investigators

• Sponsor: Instituto Cardiovascular de Buenos Aires
• Collaborators: Lucrecia Maria Burgos; Mirta Diez; Fernando Botto

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 090920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No