Adherence of Diuretics in Pulmonary Hypertension

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05167968
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marie-Camille Chaumais, PharmD, PhD
Principal Investigator Affiliation Bicêtre Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Precapillary Pulmonary Hypertension
Additional Details

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Bicêtre - Pneumology department, Le Kremlin-Bicêtre, France

Status

Recruiting

Address

Hospital Bicêtre - Pneumology department

Le Kremlin-Bicêtre, , 94275

Site Contact

Marie-Camille Chaumais, PharmD, PhD

mariecamille.chaumais@aphp.fr

+33 1.45.21.71.72

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

Submit Feedback

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation in a clinical trial or study.