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

Primary Purpose

Heart Failure, Acute Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
CAVAL US-guided Therapy
Standard of care
Sponsored by
Instituto Cardiovascular de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Cardiovascular de Buenos Aires
  • Instituto Cardiovascular de Buenos AiresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAVAL US group

Standard of care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Subclinical congestion at discharge

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2020
Last Updated
July 20, 2022
Sponsor
Instituto Cardiovascular de Buenos Aires
Collaborators
Lucrecia María Burgos, Mirta Diez, Fernando Botto
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1. Study Identification

Unique Protocol Identification Number
NCT04549701
Brief Title
Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure
Acronym
CAVAL US-AHF
Official Title
Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Cardiovascular de Buenos Aires
Collaborators
Lucrecia María Burgos, Mirta Diez, Fernando Botto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAVAL US group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CAVAL US-guided Therapy
Intervention Description
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
Intervention Name(s)
Standard of care
Intervention Description
Standard of care will be provided.
Primary Outcome Measure Information:
Title
Subclinical congestion at discharge
Time Frame
Discharge
Secondary Outcome Measure Information:
Title
Readmission for heart failure, unplanned visit for worsening HF, or death.
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Instituto Cardiovascular de Buenos Aires
City
Buenos Aires
State/Province
Buenos Aires City
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucrecia Burgos, MD
Email
Lburgos@icba.com.ar
Facility Name
Instituto Cardiovascular de Buenos Aires
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucrecia Maria Burgos
Phone
541141057500
Email
lburgos@icba.com.ar
First Name & Middle Initial & Last Name & Degree
Lucrecia M Burgos, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36344108
Citation
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.
Results Reference
derived

Learn more about this trial

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

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