Pulmonary Arterial Hypertension (PAH)
Conditions
Keywords
PAH, adherence, iloprost
Brief summary
Pulmonary Arterial Hypertension is a rare and progressive condition that compromises pulmonary circulation and can lead to right ventricular failure. Despite recent advances in diagnosis and treatment, the median survival of patients is only 2.8 years. The treatment for this disease is based on drugs that act on three main pathways: prostacyclin, endothelin, and nitric oxide. Iloprost, a prostacyclin analogue available in an inhaled form, is an important and well-established treatment. However, its mandatory frequent administration, the need for a specific inhalation technique, and its adverse event profile make its use complex. Although pharmacotherapeutic and inhalation technique follow-up by a qualified professional is widely studied in diseases like asthma and COPD, its application in Pulmonary Arterial Hypertension still lacks evidence. Thus, this study aims to evaluate how a pharmacist's intervention can improve treatment adherence, mitigate side effects and difficulties associated with inhalation, in addition to optimizing clinical and hemodynamic outcomes in patients with Pulmonary Arterial Hypertension using iloprost.
Interventions
DEVICEThe patients will receive guidance on inhaler use and adherence
The patients will receive guidance on inhaler use and adherence
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients aged 18 years or older who are treated at the reference center for PH at the Heart Institute of the University of São Paulo School of Medicine will be included in the study. Participants must have an invasive diagnostic confirmation of PAH (MPAP greater than 20 mmHg at rest, presence of PVR equal to or greater than 2 Wood units, and a PCWP equal to or less than 15 mmHg), and be on a stable dose of Iloprost for at least 12 weeks before the study begins. The patients' clinical, laboratory, exercise, hemodynamic, and medication adherence data will be collected at two points: before the start of the study and at the end. Patients who are unable to perform the 6MWT or who have had gastrointestinal bleeding within the last 12 weeks before the start of the study will be excluded. Patients will be monitored for 20 weeks. Patients will be randomized in a 1:1 ratio into an intervention group (pharmaceutical care) and a control group (standard care).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* "Adult patients aged ≥ 18 years, treated at the referral center for PH management at the Heart Institute of the University of São Paulo Medical School, with an invasive confirmed diagnosis of PAH (mean pulmonary arterial pressure \[mPAP\] greater than 20 mmHg at rest, pulmonary vascular resistance \[PVR\] equal to or greater than 2 Wood units, and pulmonary capillary wedge pressure \[PCWP\] equal to or less than 15 mmHg), and who have been using Iloprost.
Exclusion criteria
* Patients who are unable to perform the 6-minute walk test (6MWT) or who have experienced gastrointestinal bleeding within the 12 weeks prior to the start of the study will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire. | over 20 weeks of follow-up | The impact of the pharmaceutical intervention on medication adherence will be measured by the Martín-Bayarre-Grau (MBG) Questionnaire, comparing scores before and after the study period. |
Countries
Brazil
Outcome results
None listed