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THE VALIDITY OF THE AEONOSE IN DISCRIMINATING DYSPNEA RESULTING FROM HEART FAILURE OR FROM PULMONARY ORIGIN


- candidate number22530
- NTR NumberNTR5388
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-aug-2015
- Secondary IDs15.07121  METC Zwolle
- Public TitleTHE VALIDITY OF THE AEONOSE IN DISCRIMINATING DYSPNEA RESULTING FROM HEART FAILURE OR FROM PULMONARY ORIGIN
- Scientific TitleTHE VALIDITY OF THE AEONOSE IN DISCRIMINATING DYSPNEA RESULTING FROM HEART FAILURE OR FROM PULMONARY ORIGIN
- ACRONYMAEONOSE HF LF
- hypothesisThe Aeonose is capable to correctly distinguish patients with dyspnea resulting from heart failure from patients with dyspnea caused by lung failure.
- Healt Condition(s) or Problem(s) studiedHeart failure, COPD
- Inclusion criteria Signed Informed consent
A diagnosis of either heart failure NYHA class II-IV or COPD GOLD severity of obstruction II-IV.
age > 40years
- Exclusion criteria Artificial cardiac pacemaker
Atrial fibrillation or atrial flutter
Acute medical events in the 6 weeks prior to inclusion (cardiac, pulmonary or otherwise if requiring an intervention)
Patients with cancer
Tracheostoma
Inability to understand the patient information
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate1-okt-2018
- Target number of participants450
- InterventionsAll participants will be asked to breath 5 minutes through the sampling setup that consists of a non-rebreathing T-valve with an active carbon filter attached to the inlet. During sampling, a nose clamp will be placed on the nose of the participant to avoid entry of non-filtered air. The first 2 minutes are used to flush the environmental influences from the lungs after which the exhaled air is measured during 3 minutes followed by a recovery period of 4 minutes. Finally, the build-in absorber is cleared during 1 minute (20 sec heating followed by 40 sec cool-down) to release the attached volatiles followed by the final measurement period of 5 minutes under influence of the clean reference air.
- Primary outcomeThe ability of the Aeonose to discriminate between patients with heart failure (NYHA class II-IV) versus COPD GOLD class II-IV
- Secondary outcome- Time involved in obtaining Aeonose read-out
- Technical or patient related problems obtaining a read-out from the Aeonose.
- Adverse effects of using the Aeonose
- Timepointssingle measurement
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESDr. A. Huisman
- CONTACT for SCIENTIFIC QUERIESMD Wouter H. van Geffen
- Sponsor/Initiator Diaconessenhuis Meppel
- Funding
(Source(s) of Monetary or Material Support)
The Enose company
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-aug-2015 - 17-okt-2015


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