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BioImpedentiometry, Lung UltraSound and cONgestion in Heart Failure

NCT02394470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-24

No results posted yet for this study

Summary

The purpose of this study is to validate non-invasive and user-friendly methods to monitor systemic and pulmonary congestion in heart failure patients.

The primary objective is to validate the role of bioimpedentiometry, pulmonary and subcutaneous ultrasound, to assess changes in total body water in patients with heart failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are

\- to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound to monitor systemic, pulmonary and peripheral district congestion in relation with clinical and laboratory variables; 2)to analyze the organizational issues related to the use of these methods.

Conditions

  • Congestive Heart Failure

Interventions

OTHER

Deuterium oxide dilution

Reference standard for total body water: deuterium oxide dilution by mass spectrometry

OTHER

Bioimpedentiometry

Bioimpedentiometry: measurement of whole body and thoracic resistance and reactance

OTHER

Lung and subcutaneous ultrasound

Ultrasound: semiquantitative scoring of lung congestion (B lines) and peripheral edema (subcutaneous echography of the ankle)

Sponsors & Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

    collaborator OTHER_GOV

  • Niguarda Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394470 on ClinicalTrials.gov