Clinical trial NCT05167968: Adherence of Diuretics in Pulmonary Hypertension
Official title: Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precapillary Pulmonary Hypertension
Keywords: Pulmonary hypertension
Right heart failure
Adherence diuretics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Precapillary PH and diuretics treatment for at least 12 months, at least 18 years old

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)
timeFrame: 2 weeks previous hospitalization
Secondary outcomes:
measure: To determine the determinants of non-adherence to diuretics
timeFrame: 12 months previous hospitalization
measure: To assess the risk of PH worsening occurrence in the non-adhesion group
timeFrame: 12 months previous hospitalization
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hospital Bicêtre - Pneumology department
Study officials:
affiliation: Bicêtre Hospital
name: Marie-Camille Chaumais, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: