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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03083717
• Other study ID #: NaNose-CHF-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: February 2, 2017
• Last updated: March 13, 2017
• Start date: April 20, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2017
• Source: Rambam Health Care Campus
• Contact: Manhal A Habib, MD, PhD
• Phone: 97247772180
• Email: Manhal.habib[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.