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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with compensated heart failure |
| ||
| Patients with decompensated heart failure |
| ||
| Healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose) | Diagnostic Test | 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 4ËšC until NA-NOSE analysis. |
| 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. |
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Inclusion Criteria:
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:
participation in another study
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Patients suffering from compensated heart failure (stable) Patients with decompensated acute heart failure Healthy subjects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manhal A Habib, MD, PhD | Contact | 97247772180 | Manhal.habib@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manhal A Habib, MD, PhD | Attending physician, Cardiology Unit, Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
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|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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