Adherence of Diuretics in Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-13

Study Completion Date

2024-01-24

Brief Summary

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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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Detailed Description

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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

Conditions

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Precapillary Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No