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

Sponsor

Instituto Cardiovascular de Buenos Aires (Other)

Overall Status

Recruiting

CT.gov ID

NCT04549701

Collaborator

Lucrecia María Burgos (Other), Mirta Diez (Other), Fernando Botto (Other)

Enrollment

Locations

Arms

11.3

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Acute Heart Failure	Other: CAVAL US-guided Therapy Other: Standard of care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)

Actual Study Start Date :

Mar 20, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Subclinical congestion at discharge [Discharge]

Secondary Outcome Measures

Readmission for heart failure, unplanned visit for worsening HF, or death. [90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Cardiovascular de Buenos Aires	Buenos Aires	Buenos Aires City	Argentina	1428
2	Instituto Cardiovascular de Buenos Aires	Buenos Aires	Ciudad Autónoma De Buenos Aires	Argentina	1428

Sponsors and Collaborators

Instituto Cardiovascular de Buenos Aires
Lucrecia María Burgos
Mirta Diez
Fernando Botto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lucrecia Maria Burgos, Principal investigator, Instituto Cardiovascular de Buenos Aires

ClinicalTrials.gov Identifier:

NCT04549701

Other Study ID Numbers:

090920

First Posted:

Sep 16, 2020

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jul 22, 2022