Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples

Study Overview
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Brief Summary
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Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples. Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes. Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields. The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.

Official Title
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Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent ≥ 18 years of age, male or female Left ventricular Ejection fraction less than 40% or known to suffer from heart failure with preserved ejection fraction In decompensated heart failure group: dyspnea with confirmation of pulmonary congestion/edema by chest x-ray Exclusion Criteria: Pericardial diseases, e.g. constrictive pericarditis, tamponade Significant congenital heart disease, up to the investigator's opinion Life-threatening or uncontrolled arrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute. Acute ST elevation myocardial infarction Pregnant women Patients with pulmonary embolism Probable alternative diagnoses that in the opinion of the investigator could account for patient's HF symptoms (i.e., dyspnea), such as: significant pulmonary disease anemia with hemoglobin <10 g/dl participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with compensated heart failure<br> | Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)<br>* 2-3 liters of breath sample will be collected in chemically inert Mylar bags. The breath samples will then be immediately transferred from the Mylar bags to Tenax sorbent tubes using a dedicated pump. Tubes will be sealed and kept in 4˚C until NA-NOSE analysis.<br>|
| Patients with decompensated heart failure<br> | Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)<br>* 2-3 liters of breath sample will be collected in chemically inert Mylar bags. The breath samples will then be immediately transferred from the Mylar bags to Tenax sorbent tubes using a dedicated pump. Tubes will be sealed and kept in 4˚C until NA-NOSE analysis.<br>|
| Healthy subjects<br> | Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)<br>* 2-3 liters of breath sample will be collected in chemically inert Mylar bags. The breath samples will then be immediately transferred from the Mylar bags to Tenax sorbent tubes using a dedicated pump. Tubes will be sealed and kept in 4˚C until NA-NOSE analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of volatile organic compounds in breath samples | Exhaled breath samples will be collected from each volunteer for characterization and identification using two different methods. The first method uses gas chromatography linked to mass spectrometry to identify and quantify the various breath volatile organic compunds (VOC's) in each group studied (compensated heart failure, decompensated heart failure and healthy subjects). The second method deploys cross-reactive nanoarrays in combination with pattern recognition methods (NaNose Technology). | Each participant's breath sample will be analysed within one week of collection. |