NCT03083717

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

February 2, 2017

Last Update Submit

March 13, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

Patients with compensated heart failure

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

Patients with decompensated heart failure

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

Healthy subjects

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

Interventions

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

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 subjectsPatients with compensated heart failurePatients with decompensated heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • significant pulmonary disease
  • anemia with hemoglobin \<10 g/dl
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Manhal A Habib, MD, PhD

    Attending physician, Cardiology Unit, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manhal A Habib, MD, PhD

CONTACT

97247772180Manhal.habib@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2017

First Posted

March 20, 2017

Study Start

April 20, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 20, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)