Hospital Bicêtre - Pneumology department
Le Kremlin-Bicêtre, 94275, France
NCT Number: NCT05167968
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
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Notify Me18 year and older
All sexes
Observational
Le Kremlin-Bicêtre, 94275, France
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:
Methodology
Evaluation of subjects and adhesion to diuretics at inclusion are recorded:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For each patient, evaluation and adhesion to diuretics at inclusion are recorded:
Time frame: 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.
Time frame: 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
Time frame: 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
Assistance Publique - Hôpitaux de Paris
Other
Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension
Acronym: PHARE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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