Precapillary Pulmonary Hypertension
Conditions
Keywords
Pulmonary hypertension, Right heart failure, Adherence diuretics
Brief summary
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
Detailed description
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
Interventions
OTHERNo intervention (Observational cohort)
For each patient, evaluation 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over 18 years old * Precapillary PH * Diuretics treatment for at least 12 months * Having given his/her non-opposition to participate
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the determinants of non-adherence to diuretics | 30 months previous hospitalization | Determinants related to the patient, treatment, disease and care will be recorded. Association between selected determinants and adherence to diuretics will be analyzed |
| To assess the risk of PH worsening occurrence in the non-adhesion group | 30 months previous hospitalization | Occurrence 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 within the 12 months preceding inclusion. Comparison of serious event prevalence in the high- and low-adherence groups |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMarie-Camille Chaumais, PharmD, PhD
Bicêtre Hospital
Outcome results
None listed