Recruiting

imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce

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.

ClinicalTrials.gov IDNCT06850792

PhaseNA

Enrollment61

SponsorUniversity of Sao Paulo General Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension

About this study

Interventions

Behavioral: Telemedicine-Based Adherence Support — The 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.

Primary outcomes

Medication Adherence (Martín-Bayarre-Grau Scale - MBG) (24 weeks (end of study period))

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Pregnancy or breastfeeding.

Study locations

InCor - Universidade de São Paulo, São Paulo, São Paulo 05048000 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.