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

May 31, 2024 updated by: Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Discharge
Discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission for heart failure, unplanned visit for worsening HF, or death.
Time Frame: 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Cardiovascular de Buenos Aires

Collaborators

Lucrecia Maria Burgos
Mirta Diez
Fernando Botto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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