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

NCT05913739 | Terminated

• 1 other identifier: ROXIC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Oxygen Deficiency

Keywords

oxygen therapy

Outcome Measures

Primary Outcomes (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.

  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.

  changes from baseline to 6th month

Secondary Outcomes (4)

• 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

• Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).

  changes from baseline to 6th month

• 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

• 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

Study Arms (2)

Oxygen Therapy

ACTIVE COMPARATOR

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

Other: Oxygen Therapy

No Oxygen Therapy

NO INTERVENTION

Participants will not received oxygen therapy

Interventions

Oxygen Therapy OTHER

Nocturnal oxygen therapy minimum 6 hours

Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Hospital of Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Related Publications (18)

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MeSH Terms

Conditions

Hypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Marc Bonnin Vilaplana

Model Details: 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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once the manuscript is accepted for publication
• Access Criteria: Study data access will be provided for collaborative purposes

Locations

ES (1)