Precapillary Pulmonary HypertensionPHARENCT05167968
Adherence of Diuretics in Pulmonary Hypertension
An observational study of Precapillary Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precapillary Pulmonary Hypertension
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2022to 24 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Precapillary PH and diuretics treatment for at least 12 months, at least 18 years old
Who may be able to join
- Men and women over 18 years old
- Precapillary PH
- Diuretics treatment for at least 12 months
- Having given his/her non-opposition to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Bicêtre - Pneumology department
Le Kremlin-Bicêtre, 94275
About this study
Official title: 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
Read the 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
- Conditions
- Precapillary Pulmonary Hypertension
- Being tested
- No intervention (Observational cohort)
- Keywords
- Pulmonary hypertension, Right heart failure, Adherence diuretics
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks previous hospitalization
Secondary outcomes (2)
To determine the determinants of non-adherence to diuretics
Determinants related to the patient, treatment, disease and care will be recorded.
Association between selected determinants and adherence to diuretics will be analyzed
Measured: 30 months previous hospitalization
To assess the risk of PH worsening occurrence in the non-adhesion group
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
Measured: 30 months previous hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start13 Jan 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precapillary Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Camille Chaumais, PharmD, PhD, Principal investigator, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167968
- Sponsor's protocol ID
- 2021-A02137-34
- Acronym
- PHARE
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05167968
- Acronym / sponsor ID
- PHARE / 2021-A02137-34
- Conditions
- Precapillary Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Right heart failure, Adherence diuretics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Precapillary PH and diuretics treatment for at least 12 months, at least 18 years old
Key inclusion criteria (4 listed)
- Men and women over 18 years old
- Precapillary PH
- Diuretics treatment for at least 12 months
- Having given his/her non-opposition to participate
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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 secondary outcomes
To determine the determinants of non-adherence to diuretics
Time frame: 30 months previous hospitalization
To assess the risk of PH worsening occurrence in the non-adhesion group
Time frame: 30 months previous hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Precapillary Pulmonary Hypertension
Not yet recruitingPhase 3
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Pulmonary Hypertension
Not yet recruitingPhase 1/2
TEPH: Telaglenastat Efficacy in Pulmonary Hypertension
Pulmonary Hypertension
Active, not recruitingPhase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
Hypertension, Pulmonary
Not yet recruitingObservational study
Correlation Between CT Pulmonary Angiography Metrics and Right Heart Catheterization Parameters in Pre-Capillary Pulmonary Hypertension
Pulmonary Hypertension, Precapillary Pulmonary Hypertension
Not yet recruiting
Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension
Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Camille Chaumais, PharmD, PhD principal investigator
Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precapillary Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Girerd (French self-administered questionnaire about adherence medication) and level of medication possession ratio (MPR) (time frame: 2 weeks previous hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.