Impact of Oxygen Therapy on Readmissions of Patients With Chronic Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
No Oxygen Therapy
Participants will not received oxygen therapy
Oxygen Therapy
Participants received nocturnal oxygen therapy (minimum 6 hours) for 6 months.
干预措施: Oxygen Therapy (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Marc Bonnin
MD, PhD. Marc Bonnin Vilaplana
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta