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

• Conditions: Heart Failure

• Registration Number: NCT03083717
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-13
• Last Update Submitted: 2017-03-13
• Study First Posted: 2017-03-20
• Last Update Posted: 2017-03-20
• Study Start: 2017-04-20
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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:

  1. significant pulmonary disease
  2. anemia with hemoglobin <10 g/dl

• participation in another study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of volatile organic compounds in breath samples	Each participant's breath sample will be analysed within one week of collection.	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).

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel