RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists

NCT ID: NCT05600218

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1

Patients with pulmonary arterial hypertension on treatment with prostacyclin IP receptor agonists because they are at intermediate risk of mortality at one year

No intervention - Observational study

Intervention Type DRUG

Real life drug evaluation

Interventions

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No intervention - Observational study

Real life drug evaluation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen Macarena

OTHER

Sponsor Role collaborator

Hospital Regional de Malaga

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen de la Victoria

OTHER

Sponsor Role collaborator

Hospital San Juan de la Cruz

OTHER

Sponsor Role collaborator

Complejo Hospitalario de Especialidades Juan Ramón Jimenez

OTHER

Sponsor Role collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

Hospital Clinico Universitario San Cecilio

OTHER

Sponsor Role collaborator

Hospital Universitario de Valme

OTHER

Sponsor Role collaborator

Hospital de Poniente

UNKNOWN

Sponsor Role collaborator

Hospital Costa del Sol

OTHER

Sponsor Role lead

Responsible Party

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Rafael Bravo Marqués

Medical Specialist, Department of Cardiology, Hospital Costa del Sol, Marbella (Malaga,) Spain

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Poniente

El Ejido, Almería, Spain

Site Status RECRUITING

Hospital San Juan de la Cruz

Úbeda, Jaén, Spain

Site Status RECRUITING

Hospital Costa del Sol

Marbella, Málaga, Spain

Site Status RECRUITING

Hospital Clinico Universitario San Cecilio

Granada, , Spain

Site Status RECRUITING

Hospital Juan Ramón Jiménez

Huelva, , Spain

Site Status RECRUITING

Hospital Regional de Malaga

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario de Valme

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rafael Bravo Marqués, PhD, MD

Role: CONTACT

034 686202746

Facility Contacts

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Joaquín Vizcaíno Ricoma

Role: primary

Bonilla Palomas Bonilla Palomas

Role: primary

Rafael Bravo Marques

Role: primary

Juan Luis Calleja Rubio

Role: primary

José Morgado García de Polavieja

Role: primary

Francisco Espíldora Hernández

Role: primary

Víctor Becerra Muñoz

Role: primary

Irene María Estrada Parra

Role: primary

Amadeo Wals Rodríguez

Role: primary

Alejandro Recio Mayoral

Role: primary

Other Identifiers

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0991-N-21

Identifier Type: -

Identifier Source: org_study_id

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