Thoracic Fluid Assessment by Contrast-enhanced Magnetic Resonance Imaging and Bioimpedance

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Heart failure (HF) is a major health problem, which is characterized by reduced cardiac function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned hospitalization are due to pulmonary congestion. There is an urgent clinical need for quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).

Primary objectives: This study evaluates the correlation between change in BIS and change in bolus kinetic parameters in response to a fluid challenge.

Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.

Study design: Prospective nonrandomized pilot study.

Study population: Healthy volunteers.

Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI contrast agent. External pressure will be applied by means of a leg-compression device in order to induce a rapid increase of the preload by blood auto-transfusion.

Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The correlation between changes in bolus kinetic parameters and thoracic impedance in response to fluid challenges.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Criteria

Inclusion Criteria:

• Age >18 years

• Informed consent.

• Body mass index between 18 and 25

Exclusion Criteria:

• End-stage renal or hepatic disease

• Pregnancy

• Mild or moderate renal insufficiency, (GFR<60 mL/min);

• Risk for developing nephrogenic systemic fibrosis;

• General contra-indications to magnetic resonance imaging

• Pro-inflammatory state, vascular endothelial dysfunction