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

Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05913739
Collaborator
(none)
36
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oxygen Therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 listA 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)
Primary Purpose:
Treatment
Official Title:
Impact of Oxygen Therapy on Readmissions of Patients With Chronic Heart Failure With Reduced Ejection Fraction
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Oxygen Therapy

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

Other: Oxygen Therapy
Nocturnal oxygen therapy minimum 6 hours
No Intervention: No Oxygen Therapy

Participants will not received oxygen therapy

Outcome Measures

Primary Outcome Measures

  1. 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. [changes from baseline to 6th month]

    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

  1. 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). [changes from baseline to 6th month]

    To analyze if the treatment with oxygen during the night rest is accompanied by reduction the biomarkers NTproBNP(pg/mL) and TnThs (pg/mL).

  2. Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM). [changes from baseline to 6th month]

    To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).

  3. Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score) [changes from baseline to 6th month]

    To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)

  4. Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score). [changes from baseline to 6th month]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marc Bonnin, MD, PhD. Marc Bonnin Vilaplana, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier:
NCT05913739
Other Study ID Numbers:
  • ROXIC
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marc Bonnin, MD, PhD. Marc Bonnin Vilaplana, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
oxygen therapy
Additional relevant MeSH terms:
Heart Failure
Hypoxia

Study Results

No Results Posted as of Jun 22, 2023