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NCT05719363Completed

Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart Failure

Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart Failure: A Proof-of-concept Pilot Study

Source: ClinicalTrials.gov · Last updated 3 Jan 2024

Brief summary (registry, in English)

This is a one-day, proof-of-concept, pilot study of portable oxygen concentrator (POC) administration and Six Minute Walk Test (6MWT) distance in patients with stable chronic heart failure.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
25 Jan 2023
Start date
11 Oct 2023
Primary completion date
21 Nov 2023
Lead sponsor
Inogen Inc.
NCT number
NCT05719363

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 11 Oct 2023 to the primary completion date, 21 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current acute decompensated HF requiring augmented therapy with vasodilator agents, and/or inotropic drugs, and/or augmented therapy or i.v. therapy with diuretics
  • History of acute coronary syndrome (unstable angina or myocardial infarction) within 3 months prior to study enrollment

Other

  • Contraindication to the use of POC
  • Patient currently hospitalized or requiring hospitalization
  • Patient unable to walk
  • Patient who should be excluded in the opinion of the investigator
  • Participation in another interventional clinical trial within 30 days of signing the Information and Consent Form (ICF)
  • Pregnant female patient

Who the study is looking for

  • Adult male or female
  • Diagnosed with chronic stable heart failure
  • NYHA functional class II to ambulatory class IV
  • Peripheral oxygen saturation on fingertip pulse oximetry (SpO2) ≤96% at rest
  • Willingness and ability to use a POC and with no allergy to cannula material
  • Patient with the capacity to provide informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Montreal Heart Institute
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.