Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05719363 |
| Other study ID # |
INO-03 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 11, 2023 |
| Est. completion date |
November 21, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Inogen Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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. A total of 20 patients will be enrolled and undergo two 6MWT on the same day, with
Inogen Rove 6 POC turned ON and turned OFF. They will be randomly assigned in a 1:1 ratio to
either perform the first 6MWT with Inogen Rove 6 POC turned ON and the second 6MWT with
Inogen Rove 6 POC turned OFF, or vice-versa (first and second 6MWT with Inogen Rove 6 POC
turned OFF and turned ON, respectively).
Study Description: 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. A total of 20 patients will be enrolled and undergo two 6MWT on
the same day, with Inogen Rove 6 POC turned ON and turned OFF. They will be randomly assigned
in a 1:1 ratio to either perform the first 6MWT with Inogen Rove 6POC turned ON and the
second 6MWT with Inogen Rove 6 POC turned OFF, or vice-versa (first and second 6MWT with
Inogen Rove 6 POC turned OFF and turned ON, respectively).
On the day of the only study visit, informed consent will be obtained, inclusion/exclusion
criteria will be assessed, and the following information will be obtained: patient
demographics, cardiovascular medical history (including heart failure history), NYHA score,
heart failure history, respiratory condition history, smoking history, review of current
heart failure medications and other cardiovascular concomitant medications.
Eligible patients will be randomly assigned (in a 1:1 ratio) to one of the following 2
sequences:
1. first 6MWT with Inogen Rove 6 POC turned ON followed by a second 6MWT with the Inogen
Rove 6 POC turned OFF, or
2. first 6MWT with the Inogen Rove 6 POC turned OFF, followed by a second 6MWT with the
Inogen Rove 6 POC turned ON.
There will be a resting period of 60 minutes between the 2 walking tests. POC administration
will be started 15 minutes prior to the 6MWT.
The following assessments/procedures will be done:
- 6MWT distance
- Peripheral oxygen saturation on fingertip pulse oximetry before the 6MWT, at 3 minutes
(middle of the 6MWT), 6 minutes (end of the 6MWT), and 9 minutes (3 minutes after the
end of the 6MWT)
- Heart rate before the 6MWT, at 3 minutes (middle of the 6MWT), at 6 minutes (end of the
6MWT), and at 9 minutes (3 minutes after the end of the 6MWT)
- Modified Borg Scale (5) assessed before the 6MWT, at 3 minutes (middle of the 6MWT), 6
minutes (end of the 6MWT), and 9 minutes (3 minutes after the end of the 6MWT) Safety
will be assessed by the monitoring of adverse events (AEs) and serious adverse events
(SAEs) related to the use of the POC as well as by evaluating the tolerance to the use
of the POC during exercise (ability to complete the 6MWT with the POC).
Objectives:
Main objectives:
To describe the effect of the Inogen Rove 6 POC on:
- 6MWT
- Oxygen saturation level on fingertip pulse oximetry collected before and at 3 minutes
(middle of the 6MWT), at 6 minutes (end of the 6MWT), and at 9 minutes (3 minutes after
the end of the 6MWT)
- Heart rate before and at 3 minutes (middle of the 6MWT), at 6 minutes (end of the 6MWT),
and at 9 minutes (3 minutes after the end of the 6MWT)
- Modified Borg Scale collected before and at 3 minutes (middle of the 6MWT), at 6 minutes
(end of the 6MWT), and at 9 minutes (3 minutes after the end of the 6MWT)
Other objectives:
To describe the effect of the Inogen Rove 6 POC on:
- Safety of the Inogen Rove 6 POC in this subject population
- Tolerance to use of the POC during exercise
Endpoints: Main endpoints:
- Walking distance during the 6MWT
- Oxygen saturation on fingertip pulse oximetry at 3 minutes (middle of the 6MWT), at 6
minutes (end of the 6MWT), and at 9 minutes (3 minutes after the end of the 6MWT)
- Heart rate at 3 minutes (middle of the 6MWT), at 6 minutes (end of the 6MWT), and at 9
minutes (3 minutes after the end of the 6MWT)
- Modified Borg Scale at 3 minutes (middle of the 6MWT), at 6 minutes (end of the 6MWT),
and at 9 minutes (3 minutes after the end of the 6MWT)
Other endpoints:
- Adverse events (AEs) and serious adverse events (SAEs)
- Ability to complete the 6MWT using the POC
Study Population: Inclusion criteria (all need to be met):
1. Adult male or female
2. Diagnosed with chronic stable heart failure
3. NYHA functional class II to ambulatory class IV
4. Peripheral oxygen saturation on fingertip pulse oximetry (SpO2) ≤96% at rest
5. Willingness and ability to use a POC and with no allergy to cannula material
6. Patient with the capacity to provide informed consent
Exclusion criteria (no exclusion criterion should be met):
1. Contraindication to the use of POC
2. Patient currently hospitalized or requiring hospitalization
3. Current acute decompensated HF requiring augmented therapy with vasodilator agents,
and/or inotropic drugs, and/or augmented therapy or i.v. therapy with diuretics
4. History of acute coronary syndrome (unstable angina or myocardial infarction) within 3
months prior to study enrollment
5. Patient unable to walk
6. Patient who should be excluded in the opinion of the investigator
7. Participation in another interventional clinical trial within 30 days of signing the
Information and Consent Form (ICF)
8. Pregnant female patient
