Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-25 @ 3:57 PM
Study NCT ID:
NCT05167968
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence of Diuretics in Pulmonary Hypertension
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHARE
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: