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NCT Number: NCT03140566

Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF

CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial. The objective is to test whether evaluation of the inferior vena cava diameter in addition to clinical assessment is superior compared to clinical assessment alone with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäres Herzzentrum Lübeck

Lübeck, 23538, Germany

About this study

Only limited evidence is available on the best method to monitor and guide decongestion in acute decompensated heart failure. Therefore, no specific guideline recommendations are made in this regard. It is unknown whether an objective congestion marker can be used to guide decongestion or such marker is only of prognostic value by identifying high-risk patients with an advanced disease state.

CAVA-ADHF is designed as prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial and aims to demonstrate effectiveness of inferior vena cava (IVC)-guided decongestion, its feasibility, and to estimate effect size and variability of clinical endpoints following the intention-to-treat principle.

After inclusion and exclusion criteria have been checked patients will be randomized:

Experimental intervention: Decongesting treatment guided by clinical assessment and ultrasound evaluation of the IVC diameter. Decongestion should lead to a maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.

Control intervention: Decongesting treatment guided by clinical assessment alone. The IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Trial intervention will end with discharge from the index hospitalization. Patients will be followed-up for 180 to 210 days after randomization.

The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalization for ADHF with dyspnea ≥NYHA III, peripheral edema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph)
  • Age ≥18 years
  • NT-proBNP >300 ng/l within 24 h after admission
  • Sufficient ultrasound visualization to evaluate IVC
  • IVCmax >2.1 cm and IVCCI ≤50 % in the baseline assessment within 24 h after admission
  • Capability to sign informed consent personally

Exclusion criteria

  • Cardiogenic shock with systolic blood pressure <90 mmHg plus end-organ hypoperfusion
  • ADHF due to significant arrhythmias
  • Severe pulmonary disease as primary cause of dyspnea
  • Simplified Modification of Diet in Renal Disease estimated glomerular filtration rate <30 ml/min/1.73 m²
  • Need for non-invasive or invasive ventilation support at baseline
  • Pregnancy
  • Participation in another interventional trial regarding heart failure treatment

Treatment and study plan

Ultrasound evaluation of the inferior vena cava diameter

Diagnostic Test

Treatment will be guided by clinical assessment and ultrasound evaluation of the inferior vena cava (IVC) diameter. Decongestion should lead to maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.

Sham ultrasound evaluation of the inferior vena cava diameter

Diagnostic Test

Teatment guided by clinical assessment alone. Decongestion should lead to relief of symptoms and signs of congestion before discharge. IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Primary outcomes

  1. Change in NT-proBNP from baseline to discharge

    Time frame: Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    The core laboratory at Luebeck will determine NT-proBNP levels for calculation of the endpoint from samples obtained at baseline and at discharge.

Secondary outcomes

  1. Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients

    Time frame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    Proportion of patients with per-protocol treatment in the experimental group.

  2. All-cause mortality

    Time frame: 180 days after randomization

    Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess vital status (all-cause mortality). In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted.

  3. Cardiovascular mortality

    Time frame: 180 days after randomization

    Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess vital status (all-cause mortality). In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted. Medical reports will be requested to adjudicate cause of death.

  4. Unscheduled readmission for any cause

    Time frame: 180 days after randomization

    Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess readmission status. In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted.

  5. Readmission for heart failure

    Time frame: 180 days after randomization

    Participants will be contacted by telephone at 180 days (180 to 210 days) after randomization to assess readmission status. In case of unavailability patients, relatives, general practitioners, and/or population register will be contacted. Medical reports will be requested to adjudicate cause of readmission.

  6. Hemoconcentration

    Time frame: Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    Hemoconcentration will be defined as a relative increase in hemoglobin from baseline to discharge.

  7. Freedom from signs of congestion at discharge

    Time frame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    Freedom from signs of congestion at discharge is defined as the absence of orthopnea, pulmonary rales, and jugular venous distension in conjunction with none or only a trace of edema at discharge.

  8. Cumulative loop diuretic dose during index hospitalization

    Time frame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    For calculation of the cumulative loop diuretic dose during index hospitalization all intrahospital applied doses of loop diuretics will be converted to intravenous furosemide equivalents and summed up. Preclinical doses applied by the emergency medical services will not be considered.

  9. Length of index hospitalization

    Time frame: Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)

    Time in days from hospital admission to hospital dicharge.

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

Ultrasound Evaluation of the Inferior Vena Cava in Addition to Clinical Assessment to Guide Decongestion in Acute Decompensated Heart Failure: a Pilot Study

Acronym: CAVA-ADHF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 4, 2017
Registry last updated
Sep 25, 2019

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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