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

Rambam Health Care Campus

Status: Unknown

Conditions: Heart Failure

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

Study type: Observational

Funder types: Other

Identifiers

NCT03083717

NaNose-CHF-2017

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Patients with compensated heart failure

Treatment:

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

Patients with decompensated heart failure

Treatment:

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

Healthy subjects

Treatment:

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