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Oxygen Therapy in Patients With Chronic Heart Failure With Reduced Ejection Fraction (ROXIC)

Primary Purpose

Chronic Heart Failure, Oxygen Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oxygen Therapy
Sponsored by
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients > 18 years old. Diagnosis and clinic of chronic heart failure with ventricular dysfunction with left ventricular ejection fraction (LVEF) <40% under optimal medical treatment regardless of its etiology and having presented at least one episode of decompensation (visits to the emergency room, hospitalizations and/or need for intravenous depletive treatment) during the last year. Nocturnal desaturation defined as mean SatO2 <90% and/or Cummulative time (TC) <90>22 minutes to nocturnal pulse oximetry done at home. Signed informed consent Exclusion Criteria: Chronic lung disease (includes chronic obstructive pulmonary disease with Pulmonary respiratory function (PRF) (forced expiratory volume at one second/forced vital capacity (FEV1/FVC) <70%), diffuse interstitial diseases, pulmonary hypertension of respiratory). Obstructive sleep apnea-hypopnea syndrome (OSAHS) with Apnea hypopnea index (AHI) > 14.9. Previous treatment with oxygen therapy. Not agreeing to attend periodic cardiology visits. Being part of other clinical studies that contraindicate an intervention. Pregnant or breastfeeding women.

Sites / Locations

  • University Hospital of Girona Dr. Josep TruetaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Oxygen Therapy

No Oxygen Therapy

Arm Description

Participants received nocturnal oxygen therapy (minimum 6 hours) for 6 months.

Participants will not received oxygen therapy

Outcomes

Primary Outcome Measures

Nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation can reduce the number of heart failure decompensations cardiac arrest.
To assess whether treatment with nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation (mean SatO2 <90% and/or CT <90%>22 minutes) no AOS manages to reduce the number of heart failure decompensations cardiac arrest (hospitalizations, visits to the emergency room or the need for depletive treatment intravenously) compared with patients not receiving oxygen therapy.

Secondary Outcome Measures

Oxygen during the night rest is accompanied by reduction of the biomarker NTproBNP (pg/mL). Oxygen during the night rest is accompanied by reduction the biomarker TnThs (pg/mL).
To analyze if the treatment with oxygen during the night rest is accompanied by reduction the biomarkers NTproBNP(pg/mL) and TnThs (pg/mL).
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).

Full Information

First Posted
February 8, 2023
Last Updated
October 3, 2023
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
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1. Study Identification

Unique Protocol Identification Number
NCT05913739
Brief Title
Oxygen Therapy in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Acronym
ROXIC
Official Title
Impact of Oxygen Therapy on Readmissions of Patients With Chronic Heart Failure With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess patients with chronic heart failure and moderate-severe ventricular dysfunction (left ventricular ejection fraction (FEVE) <40%) with nocturnal desaturation (mean Oxygen saturation (SatO2) <90% and/or Cummulative time (TC) <90% > 22 minutes) without underlying respiratory disease, oxygen treatment during hours of night rest will reduce exacerbations, improve the ability to effort, sleep quality and poor prognostic parameters of heart failure, compared to patients not receiving oxygen treatment.
Detailed Description
36 patients will attend at baseline, monthly, 3-month and 6-monthly visits. BASELINE VISIT After being informed about the study and potential risks, all patients giving written informed consent, will be randomized (according to the list) receiving oxygen therapy (treatment group) and those not receiving this treatment (control group). The following information will be collected: Demographics, pathological history, concomitant medication. Physical examination, vital signs (pressure, heart rate, weight) Doppler echocardiography (an echocardiography performed in the last 6 months will be accepted) Analytical determination of biomarkers NT-proBNP and ultrasensitive troponin. Assessment of baseline functional class by NYHA classification. Respiratory function tests: spirometry and diffusion (will accept tests performed in the last 6 months). Arterial blood gases. Nocturnal respiratory polygraphy. Exercise capacity with the 6-minute walk test (P6MM) Evaluation of health-related quality of life with the Minnesota questionnaire Assessment of sleep quality using the Pittsburgh questionnaire If the patient belongs to the treatment group, the intervention will begin with oxygen therapy with a static concentrator and nasal cannula during the night at home, with a minimum compliance of six hours, following the usual clinical practice. Overnight pulse oximetry at home with oxygen will be performed to confirm if the prescribed flow rate is adequate to achieve a mean SatO2 >90% and/or that the correction of the CT90. If this is not achieved, it will be repeated, modifying the oxygen flow until the target is reached. The control group will not undergo this intervention. The rest of the medical treatment will be carried out according to the usual protocol of the Heart Failure Unit. Follow up visits: Clinical follow-up will be done at one month, three months and six months after the start of the intervention in the Chronic Respiratory Pathology Unit of Pneumology. At 1 and 3 months Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs). Baseline functional class will be collected by New York Heart Association (NYHA) classification. Physical examination, vital signs (blood pressure (BP), Heart rate (HR), weight). Adverse effects and concomitant medication. At 6 months Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs). Baseline functional class by NYHA classification will be collected. Physical examination, vital signs (BP, HR, weight). Evaluation of exercise capacity will be done by means of the 6-minute walk test (PM6M). Nocturnal pulse oximetry of control: treatment group with oxygen to evaluate the response and control group without oxygen to evaluate the evolution. Assessment of health-related quality of life with the Minnesota questionnaire. Sleep quality will be assessed using the Pittsburgh questionnaire. Adverse effects and concomitant medication. In the follow-up periods (1, 3 and 6 months), the number of decompensations will be recorded: Hospitalizations for heart failure. Emergency care for heart failure requiring at least one dose of intravenous diuretic treatment. Need for outpatient intravenous depletive treatment due to the presence of congestive signs. The study will be considered completed after 6 months of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Oxygen Deficiency
Keywords
oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomization of the patients will be carried out receiving oxygen therapy (treatment group) and those not receiving this treatment (control group): randomization will be done according to list
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygen Therapy
Arm Type
Active Comparator
Arm Description
Participants received nocturnal oxygen therapy (minimum 6 hours) for 6 months.
Arm Title
No Oxygen Therapy
Arm Type
No Intervention
Arm Description
Participants will not received oxygen therapy
Intervention Type
Other
Intervention Name(s)
Oxygen Therapy
Intervention Description
Nocturnal oxygen therapy minimum 6 hours
Primary Outcome Measure Information:
Title
Nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation can reduce the number of heart failure decompensations cardiac arrest.
Description
To assess whether treatment with nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation (mean SatO2 <90% and/or CT <90%>22 minutes) no AOS manages to reduce the number of heart failure decompensations cardiac arrest (hospitalizations, visits to the emergency room or the need for depletive treatment intravenously) compared with patients not receiving oxygen therapy.
Time Frame
changes from baseline to 6th month
Secondary Outcome Measure Information:
Title
Oxygen during the night rest is accompanied by reduction of the biomarker NTproBNP (pg/mL). Oxygen during the night rest is accompanied by reduction the biomarker TnThs (pg/mL).
Description
To analyze if the treatment with oxygen during the night rest is accompanied by reduction the biomarkers NTproBNP(pg/mL) and TnThs (pg/mL).
Time Frame
changes from baseline to 6th month
Title
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
Description
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
Time Frame
changes from baseline to 6th month
Title
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
Description
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
Time Frame
changes from baseline to 6th month
Title
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
Description
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
Time Frame
changes from baseline to 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years old. Diagnosis and clinic of chronic heart failure with ventricular dysfunction with left ventricular ejection fraction (LVEF) <40% under optimal medical treatment regardless of its etiology and having presented at least one episode of decompensation (visits to the emergency room, hospitalizations and/or need for intravenous depletive treatment) during the last year. Nocturnal desaturation defined as mean SatO2 <90% and/or Cummulative time (TC) <90>22 minutes to nocturnal pulse oximetry done at home. Signed informed consent Exclusion Criteria: Chronic lung disease (includes chronic obstructive pulmonary disease with Pulmonary respiratory function (PRF) (forced expiratory volume at one second/forced vital capacity (FEV1/FVC) <70%), diffuse interstitial diseases, pulmonary hypertension of respiratory). Obstructive sleep apnea-hypopnea syndrome (OSAHS) with Apnea hypopnea index (AHI) > 14.9. Previous treatment with oxygen therapy. Not agreeing to attend periodic cardiology visits. Being part of other clinical studies that contraindicate an intervention. Pregnant or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Bonnin Vilaplana, MD
Phone
+34 972 94 02 00
Ext
2364
Email
mbonnin.girona.ics@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Torrente Nieto
Phone
+34 972 94 02 00
Ext
2364
Email
atorrente.girona.ics@gencat.cat
Facility Information:
Facility Name
University Hospital of Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Bonnin, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD) collected data can be shared as long as it is for research collaboration
IPD Sharing Time Frame
Once the manuscript is accepted for publication
IPD Sharing Access Criteria
Study data access will be provided for collaborative purposes
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Oxygen Therapy in Patients With Chronic Heart Failure With Reduced Ejection Fraction

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