Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
NCT ID: NCT03083717
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-04-20
2020-01-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with compensated heart failure
Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
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.
Patients with decompensated heart failure
Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
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.
Healthy subjects
Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
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.
Interventions
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Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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:
1. significant pulmonary disease
2. anemia with hemoglobin \<10 g/dl
* participation in another study
18 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Manhal Habib MD, PhD
Principal investigator
Principal Investigators
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Manhal A Habib, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Attending physician, Cardiology Unit, Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NaNose-CHF-2017
Identifier Type: -
Identifier Source: org_study_id
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