Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Precapillary Pulmonary Hypertension
- 发起方
- Assistance Publique - Hôpitaux de Paris
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
In this prospective study, the investigators will implement a systematic assessment of adherence to diuretics in a cohort of patients with precapillary pulmonary hypertension.
This study is designed to:
- determine the overall adherence rates for diuretic regimen
- determine the determinants of non-adherence to diuretics
- assess the risk of PH worsening occurrence in the non-adhesion group
详细描述
Introduction Precapillary pulmonary hypertension (PH) is characterized by remodeling of small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance (PVR) resulting to right heart failure and ultimately death. The prognosis of PH is closely related to the ability of the right ventricle to adapt to the progressive increase in PVR. The occurrence of acute right ventricular decompensation is associated with a very poor prognosis at short term. The management of precapillary PH is based on specific therapies combined with general measures and supportive therapies. Diuretic treatment is recommended in PAH patients with signs of RV failure and fluid retention (recommendation class I, level of evidence C). The beneficial effect of diuretics is probably essential for preventing episodes of acute right ventricular decompensation. However, no study analyzed the rate of adherence to diuretic regimen in PH patients and the impact of patterns of adherence to diuretics on the outcomes of patients. Aim and objectives The main objectives of this study are to: * determine the overall adherence rates for diuretic regimen * determine the determinants of non-adherence to diuretics * assess the risk of PH worsening occurrence in the non-adherence group Methodology Evaluation of subjects and adhesion to diuretics at inclusion are recorded: * Self-questioning of medication adherence: Girerd questionnaire * Assessment of the Medication Possession Ratio * Social and demographic data * Comorbidities * PH characteristics * Clinical evaluation: dyspnea assessed by NYHA functional class (New York Heart Association Functional Classification : I-IV), signs of right heart failure * Type of treatment regimen * History of serious events including non-programmed hospitalization for PH and/or worsening of the disease (15% reduction in the 6-minute walking test and worsening of the WHO functional class) and/or the need to reinforce specific PH therapies
研究者
入排标准
入选标准
- •Men and women over 18 years old
- •Precapillary PH
- •Diuretics treatment for at least 12 months
- •Having given his/her non-opposition to participate
排除标准
- •Treatment regimen without diuretics
- •Diuretics treatment for less than 12 months
- •Postcapillary PH
- •People refusing or unable to give informed consent
- •No affiliation to a regime of social security.
- •Protected patients
结局指标
主要结局
Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)
时间窗: 2 weeks previous hospitalization
Prevalence of high adherence to diuretics in PH patients Girerd questionnaire is made up of 6 items which are evaluated in a binary way : Yes = 0 point \& No = 1 point. Three medication categories are defined : high adherence (score = 6), moderate adherence (score = 4 or 5) and low adherence (score \< or = 3). MPR is defined by the ratio between the number of days during which the patient is supplied for his medication and the number of days during he should be supplied his medication, over a given period (12 months). Patients with a MPR \> 0,80 are considered to have a high adherence whereas patients with a MPR \< 0,80 are considered to have a low adherence to diuretics.
次要结局
- To determine the determinants of non-adherence to diuretics(30 months previous hospitalization)
- To assess the risk of PH worsening occurrence in the non-adhesion group(30 months previous hospitalization)