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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05600218
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital Costa del Sol
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

: 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

Interventions

Drug: - No intervention - Observational study

Real life drug evaluation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital de Poniente, El Ejido, Almería, Spain

Status

Recruiting

Address

Hospital de Poniente

El Ejido, Almería,

Site Contact

Joaquín Vizcaíno Ricoma

rafabravomarques@gmail.com

034 686202746

Hospital San Juan de la Cruz, Úbeda, Jaén, Spain

Status

Recruiting

Address

Hospital San Juan de la Cruz

Úbeda, Jaén,

Site Contact

Bonilla Palomas Bonilla Palomas

rafabravomarques@gmail.com

034 686202746

Hospital Costa del Sol, Marbella, Málaga, Spain

Status

Recruiting

Address

Hospital Costa del Sol

Marbella, Málaga,

Site Contact

Rafael Bravo Marques

rafabravomarques@gmail.com

034 686202746

Granada, Spain

Status

Recruiting

Address

Hospital Clinico Universitario San Cecilio

Granada, ,

Site Contact

Juan Luis Calleja Rubio

rafabravomarques@gmail.com

034 686202746

Hospital Juan Ramón Jiménez, Huelva, Spain

Status

Recruiting

Address

Hospital Juan Ramón Jiménez

Huelva, ,

Site Contact

José Morgado García de Polavieja

rafabravomarques@gmail.com

034 686202746

Hospital Regional de Malaga, Málaga, Spain

Status

Recruiting

Address

Hospital Regional de Malaga

Málaga, ,

Site Contact

Francisco Espíldora Hernández

rafabravomarques@gmail.com

034 686202746

Málaga, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Málaga, ,

Site Contact

Víctor Becerra Muñoz

rafabravomarques@gmail.com

034 686202746

Hospital Universitario de Valme, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario de Valme

Sevilla, ,

Site Contact

Irene María Estrada Parra

rafabravomarques@gmail.com

034 686202746

Hospital Universitario Virgen del Rocío, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen del Rocío

Sevilla, ,

Site Contact

Amadeo Wals Rodríguez

rafabravomarques@gmail.com

034 686202746

Hospital Universitario Virgen Macarena, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena

Sevilla, ,

Site Contact

Alejandro Recio Mayoral

rafabravomarques@gmail.com

034 686202746

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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