Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 109 for:    guide | heart failure

Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF (CAVA-ADHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140566
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Holger Thiele, University of Luebeck

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: Ultrasound evaluation of the inferior vena cava diameter Diagnostic Test: Sham ultrasound evaluation of the inferior vena cava diameter Not Applicable

Detailed Description:

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Ultrasound Evaluation of the Inferior Vena Cava in Addition to Clinical Assessment to Guide Decongestion in Acute Decompensated Heart Failure: a Pilot Study
Actual Study Start Date : June 3, 2017
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clinical assessment plus IVC diameter
Decongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter
Diagnostic Test: Ultrasound evaluation of the inferior vena cava diameter
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 Comparator: Clinical assessment only
Decongesting treatment guided by clinical assessment alone
Diagnostic Test: Sham ultrasound evaluation of the inferior vena cava diameter
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140566


Locations
Layout table for location information
Germany
Universitäres Herzzentrum Lübeck
Lübeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Layout table for additonal information
Responsible Party: Holger Thiele, Director, University of Luebeck
ClinicalTrials.gov Identifier: NCT03140566    
Other Study ID Numbers: CAVA-ADHF-DZHK10
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holger Thiele, University of Luebeck:
heart failure
acute decompensated heart failure
congestion
inferior vena cava
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases