Adherence of Diuretics in Pulmonary Hypertension — PHARE  

Precapillary Pulmonary Hypertension Clinical Trial

Official title: Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Precapillary Pulmonary Hypertension

• NCT number: NCT05167968
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie-Camille Chaumais, PharmD, PhD
• Phone: 33 (1).45.21.71.72
• Email: mariecamille.chaumais@aphp.fr
• Status: Recruiting
• Start date: January 13, 2022
• Completion date: January 13, 2023