Pulmonary arterial hypertension (PAH) is a progressive condition with high morbidity, frequent hospitalizations, and risk of right heart failure. Despite advances in treatment, poor adherence remains a major challenge. This randomized controlled study assesses whether remote monitoring can improve treatment adherence, clinical outcomes, and side effect management in PAH patients on oral therapy.
Adults aged ≥18 years diagnosed with pulmonary arterial hypertension (PAH) (Group 1 of the WHO classification).
Stable oral PAH therapy (including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin pathway agents) for at least four weeks prior to enrollment.
Ability to participate in remote teleconsultations (access to a phone or internet).
Signed informed consent agreeing to study participation.
Severe cognitive impairment or psychiatric disorders that could affect adherence or study participation.
Inability to communicate via phone or telemedicine due to technical or personal constraints.
Concurrent participation in another interventional clinical trial that could interfere with outcomes.
Life expectancy <6 months due to any condition unrelated to PAH.
Single group
Telemedicine-Based Adherence Support
BehavioralThe intervention consists of biweekly teleconsultations for six months, conducted by healthcare professionals, focusing on medication adherence, patient education, side effect management, and remote support for individuals with pulmonary arterial hypertension (PAH). Patients will receive structured guidance on treatment adherence, tailored counseling, and real-time problem-solving strategies. The goal is to improve adherence to oral PAH therapy and enhance clinical outcomes compared to standard care.
Medication Adherence (Martín-Bayarre-Grau Scale - MBG)
Adherence to oral pulmonary arterial hypertension (PAH) therapy will be evaluated using the Martín-Bayarre-Grau (MBG) scale, a validated questionnaire assessing adherence behaviors such as medication timing, dose compliance, and integration into daily routines. The scale generates a quantitative score ranging from 0 to 100, with higher values reflecting better adherence. The study will compare MBG scores obtained at baseline and after 24 weeks of biweekly teleconsultations to assess the impact of the telemedicine intervention on treatment adherence in a pre-post design.
Functional Class (WHO/NYHA Classification)
Functional class will be assessed using the World Health Organization (WHO)/New York Heart Association (NYHA) classification, which categorizes the severity of symptoms and physical activity limitations in patients with pulmonary arterial hypertension (PAH). The classification ranges from Class I (no symptoms) to Class IV (symptoms at rest). Changes in functional class will be evaluated by comparing baseline and 24-week assessments to determine the impact of the telemedicine intervention on clinical status.
Six-Minute Walk Test (6MWT) Distance
Distance walked during the six-minute walk test (6MWT) will be measured to evaluate functional capacity and exercise tolerance in patients with pulmonary arterial hypertension (PAH). The test will be conducted at baseline and after 24 weeks of telemedicine follow-up. Changes in the distance walked (in meters) will be analyzed to assess the impact of the intervention on physical performance.
Brain Natriuretic Peptide (BNP) Levels
BNP levels, a biomarker for right ventricular function and PAH severity, will be measured at baseline and at 24 weeks to assess changes in cardiac strain.
Risk Stratification (COMPERA 2.0)
PAH risk stratification scores using COMPERA 2.0 will be calculated at baseline and at 24 weeks to assess changes in disease severity.
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