NCT05719363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

January 25, 2023

Last Update Submit

January 2, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (10)

  • Walking distance during the 6MWT

    Walking distance during the 6MWT

    6 minutes

  • Oxygen saturation

    Oxygen saturation on fingertip pulse oximetry

    At 3 minutes (middle of the 6MWT)

  • Oxygen saturation

    Oxygen saturation on fingertip pulse oximetry

    At 6 minutes (end of the 6MWT)

  • Oxygen saturation

    Oxygen saturation on fingertip pulse oximetry

    At 9 minutes (3 minutes after the end of the 6MWT)

  • Heart rate

    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)

  • Modified Borg Scale

    Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.

    At 3 minutes (middle of the 6MWT)

  • Modified Borg Scale

    Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.

    At 6 minutes (end of the 6MWT)

  • Modified Borg Scale

    Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.

    At 9 minutes (3 minutes after the end of the 6MWT)

Secondary Outcomes (2)

  • Adverse Events

    Study period of approximately 5 hour on study day.

  • Tolerance to POC

    6 minutes

Study Arms (2)

POC ON

EXPERIMENTAL

6MWT with Inogen Rove 6 POC turned ON

Device: Inogen Rove 6 Portable Oxygen Concentrator

POC OFF

SHAM COMPARATOR

6MWT with Inogen Rove 6 POC turned OFF

Device: Inogen Rove 6 Portable Oxygen Concentrator

Interventions

Inogen Rove 6 Portable Oxygen ConcentratorDEVICE

The Inogen Rove 6 POC is designed to provide a flow of high-purity oxygen. Inogen Rove 6 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 Rove 6 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.

POC OFFPOC ON

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 9, 2023

Study Start

October 11, 2023

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Locations

CA(1)