Heart FailureNCT03083717
Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
An observational study of Heart Failure, run by Rambam Health Care Campus at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Apr 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from compensated heart failure (stable) Patients with decompensated acute heart failure Healthy subjects
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa, 3109601
Manhal A Habib, MD, PhD, 97247772180, Manhal.habib@gmail.com
About this study
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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with compensated heart failure | Not described Receives: Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose) | |
| Patients with decompensated heart failure | Not described Receives: Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose) | |
| Healthy subjects | Not described Receives: Diagnostic Test: Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Each participant's breath sample will be analysed within one week of collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start20 Apr 2017 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manhal Habib MD, PhD, Rambam Health Care Campus
- Investigators
- Manhal A Habib, MD, PhD, Principal investigator, Attending physician, Cardiology Unit, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083717
- Sponsor's protocol ID
- NaNose-CHF-2017
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2017
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
- ClinicalTrials.gov ID
- NCT03083717
- Acronym / sponsor ID
- NaNose-CHF-2017
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 20 Apr 2017 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from compensated heart failure (stable) Patients with decompensated acute heart failure Healthy subjects
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Healthy subjects, Patients with compensated heart failure, Patients with decompensated heart failure |
Primary outcome
Detection of volatile organic compounds in breath samples
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manhal A Habib, MD, PhD principal investigator
Attending physician, Cardiology Unit, Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manhal A Habib, MD, PhD (97247772180, Manhal.habib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of volatile organic compounds in breath samples (time frame: Each participant's breath sample will be analysed within one week of collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.