Clinical trial NCT05600218: RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
Official title: Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
Selexipag
Real World Data
Effectiveness
Lead sponsor: Hospital Costa del Sol
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen Macarena
name: Hospital Regional de Malaga
name: Hospital Universitario Virgen de la Victoria
name: Hospital San Juan de la Cruz
name: Complejo Hospitalario de Especialidades Juan Ramón Jimenez
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Clinico Universitario San Cecilio
name: Hospital Universitario de Valme
name: Hospital de Poniente
First posted: 2022-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary arterial hypertension (mostly intermediate risk patients) who are started on treatment with Selexipag according to clinical practice guideline recommendations.

Brief summary: This is an observational, ambrispective study of patients in real world clinical practice, who has pulmonary arterial hypertension in whom a prostacyclin IP receptor agonist (Selexipag) is initiated between 2017 and 2021.

The aim of this study answer the following questions:

* Changes in the mortality risk profile of these patients after treatment administration.
* Baseline characteristics of patients initiating Selexipag.
* Parameters used for risk stratification prior to treatment escalation.
* Events during follow-up.

No comparison group available


Eligibility criteria: Inclusion Criteria:

* They agree to participate in the study by signing an informed consent form

Exclusion Criteria:

* Decline to participate in the study
* Patients living 6 months or less in the reference health area
* Patients with active malignant tumors

Primary outcomes:
measure: Clinical improvement (risk profile)
timeFrame: 12 months
Secondary outcomes:
measure: Risk stratification variables
timeFrame: Basaline
measure: Events
timeFrame: 12 months
Other outcomes:
Locations:
city: El Ejido
country: Spain
facility: Hospital de Poniente
state: Almería
city: Úbeda
country: Spain
facility: Hospital San Juan de la Cruz
state: Jaén
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Granada
country: Spain
facility: Hospital Clinico Universitario San Cecilio
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Regional de Malaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
References: