Adherence of Diuretics in Pulmonary Hypertension (PHARE)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Precapillary Pulmonary Hypertension

Treatments

Other: No intervention (Observational cohort)

Study type

Observational

Funder types

Other

Identifiers

NCT05167968

2021-A02137-34

Details and patient eligibility

About

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

Full 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