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Completed

NCT Number: NCT04549701

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Cardiovascular de Buenos Aires, Buenos Aires, Buenos Aires City, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAVAL US-guided Therapy

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

Other

Standard of care will be provided.

Primary outcomes

  1. Subclinical congestion at discharge

    Time frame: Discharge

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Cardiovascular de Buenos Aires

Other

Registry information

Official study title

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

Acronym: CAVAL US-AHF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2020
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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