Adherence of Diuretics in Pulmonary Hypertension

NCT05167968 | Completed

• 1 other identifier: 2021-A02137-34
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

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

Conditions

Precapillary Pulmonary Hypertension

Keywords

Pulmonary hypertension; Right heart failure; Adherence diuretics

Outcome Measures

Primary Outcomes (1)

• Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR)

  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 Outcomes (2)

• To determine the determinants of non-adherence to diuretics

  30 months previous hospitalization

• To assess the risk of PH worsening occurrence in the non-adhesion group

  30 months previous hospitalization

Interventions

No intervention (Observational cohort) OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Men and women over 18 years old
• Precapillary PH
• Diuretics treatment for at least 12 months
• Having given his/her non-opposition to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Bicêtre - Pneumology department

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Marie-Camille Chaumais, PharmD, PhD

  Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 22, 2021
• Study Start: January 13, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)