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

Sponsor

Inogen Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05719363

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Inogen One® G5 Portable Oxygen Concentrator	N/A

Detailed 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 One® G5 POC turned ON and turned OFF. They will be randomly assigned in a 1:1 ratio to either perform the first 6MWT with Inogen One® G5 POC turned ON and the second 6MWT with Inogen One® G5 POC turned OFF, or vice-versa (first and second 6MWT with Inogen One® G5 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 One® G5 POC turned ON and turned OFF. They will be randomly assigned in a 1:1 ratio to either perform the first 6MWT with Inogen One® G5 POC turned ON and the second 6MWT with Inogen One® G5 POC turned OFF, or vice-versa (first and second 6MWT with Inogen One® G5 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:

first 6MWT with Inogen One® G5 POC turned ON followed by a second 6MWT with the Inogen One® G5 POC turned OFF, or
first 6MWT with the Inogen One® G5 POC turned OFF, followed by a second 6MWT with the Inogen One® G5 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 One® G5 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 One® G5 POC on:

Safety of the Inogen One® G5 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):

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

Exclusion criteria (no exclusion criterion should be met):

Contraindication to the use of POC
Patient currently hospitalized or requiring hospitalization
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
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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Masking Description:

All patients will have the nasal cannula in place during both 6MWTs, but the POC will be activated only during the test conducted with oxygen supplementation

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: POC ON 6MWT with Inogen One® G5 POC turned ON	Device: Inogen One® G5 Portable Oxygen Concentrator The Inogen One® G5 POC is designed to provide a flow of high-purity oxygen. Inogen One G5 is a highly versatile and robust concentrator which offers patients the option to use up to 6 different flow settings. The unit weighs just under 5 pounds. Utilizing an Intelligent delivery technology, the unit can provide patients with required oxygen therapy on a 24/7 basis. The Inogen One® G5 POC will be used for patients with chronic heart failure as an investigational device. It supplies a high concentration of oxygen and is used with a nasal cannula which channels oxygen from the concentrator to the patient.
Sham Comparator: POC OFF 6MWT with Inogen One® G5 POC turned OFF	Device: Inogen One® G5 Portable Oxygen Concentrator The Inogen One® G5 POC is designed to provide a flow of high-purity oxygen. Inogen One G5 is a highly versatile and robust concentrator which offers patients the option to use up to 6 different flow settings. The unit weighs just under 5 pounds. Utilizing an Intelligent delivery technology, the unit can provide patients with required oxygen therapy on a 24/7 basis. The Inogen One® G5 POC will be used for patients with chronic heart failure as an investigational device. It supplies a high concentration of oxygen and is used with a nasal cannula which channels oxygen from the concentrator to the patient.

Arm

Intervention/Treatment

Experimental: POC ON

6MWT with Inogen One® G5 POC turned ON

Device: Inogen One® G5 Portable Oxygen Concentrator

The Inogen One® G5 POC is designed to provide a flow of high-purity oxygen. Inogen One G5 is a highly versatile and robust concentrator which offers patients the option to use up to 6 different flow settings. The unit weighs just under 5 pounds. Utilizing an Intelligent delivery technology, the unit can provide patients with required oxygen therapy on a 24/7 basis. The Inogen One® G5 POC will be used for patients with chronic heart failure as an investigational device. It supplies a high concentration of oxygen and is used with a nasal cannula which channels oxygen from the concentrator to the patient.

Sham Comparator: POC OFF

6MWT with Inogen One® G5 POC turned OFF

Device: Inogen One® G5 Portable Oxygen Concentrator

Outcome Measures

Primary Outcome Measures

Walking distance during the 6MWT [6 minutes]
Walking distance during the 6MWT
Oxygen saturation [At 3 minutes (middle of the 6MWT)]
Oxygen saturation on fingertip pulse oximetry
Oxygen saturation [At 6 minutes (end of the 6MWT)]
Oxygen saturation on fingertip pulse oximetry
Oxygen saturation [At 9 minutes (3 minutes after the end of the 6MWT)]
Oxygen saturation on fingertip pulse oximetry
Heart rate [At 3 minutes (middle of the 6MWT)]
Heart rate
Heart rate [At 6 minutes (end of the 6MWT)]
Heart rate
Heart rate [At 9 minutes (3 minutes after the end of the 6MWT)]
Heart rate
Modified Borg Scale [At 3 minutes (middle of the 6MWT)]
Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.
Modified Borg Scale [At 6 minutes (end of the 6MWT)]
Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.
Modified Borg Scale [At 9 minutes (3 minutes after the end of the 6MWT)]
Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.

Secondary Outcome Measures

Adverse Events [Study period of approximately 5 hour on study day.]
Adverse events (AEs) and serious adverse events (SAEs)
Tolerance to POC [6 minutes]
Ability (yes or no) to complete the 6MWT with the POC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contraindication to the use of POC
Patient currently hospitalized or requiring hospitalization
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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montreal Heart Institute	Montréal	Quebec	Canada	H1T1C8

Sponsors and Collaborators

Inogen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inogen Inc.

ClinicalTrials.gov Identifier:

NCT05719363

Other Study ID Numbers:

INO-03

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Feb 10, 2023