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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from compensated heart failure (stable) Patients with decompensated acute heart failure Healthy subjects

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	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.
Patients with compensated heart failure	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.
Patients with decompensated heart failure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Manhal A Habib, MD, PhD, Attending physician, Cardiology Unit, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NaNose-CHF-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No