Adherence of Diuretics in Pulmonary Hypertension (PHARE)

February 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94275
        • Hospital Bicêtre - Pneumology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Precapillary PH and diuretics treatment for at least 12 months, at least 18 years old

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)
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.
2 weeks previous hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the determinants of non-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
30 months previous hospitalization
To assess the risk of PH worsening occurrence in the non-adhesion group
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
30 months previous hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie-Camille Chaumais, PharmD, PhD, Bicetre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02137-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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