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

NCT05600218 | Unknown FDA Drug

• 1 other identifier: 0991-N-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 10

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

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Selexipag; Real World Data; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Clinical improvement (risk profile)

  Percentage of patients reducing annual mortality risk profile according to ESC/ERS Clinical Practice Guidelines 2015 Risk Stratification.

  12 months

Secondary Outcomes (2)

• Risk stratification variables

  Basaline

• Events

  12 months

Study Arms (1)

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

Drug: No intervention - Observational study

Interventions

No intervention - Observational study DRUG

Real life drug evaluation

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Costa del Sol: lead
• Hospital Universitario Virgen Macarena: collaborator
• Hospital Regional de Malaga: collaborator
• Hospital Universitario Virgen de la Victoria: collaborator
• Hospital San Juan de la Cruz: collaborator
• Complejo Hospitalario de Especialidades Juan Ramón Jimenez: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator
• Hospital Universitario de Valme: collaborator
• Hospital de Poniente: collaborator

Study Sites (10)

Hospital de Poniente

El Ejido, Almería, Spain

RECRUITING

Hospital San Juan de la Cruz

Úbeda, Jaén, Spain

RECRUITING

Hospital Costa del Sol

Marbella, Málaga, Spain

RECRUITING

Hospital Clinico Universitario San Cecilio

Granada, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Hospital Regional de Malaga

Málaga, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Universitario de Valme

Seville, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Rafael Bravo Marqués, PhD, MD

CONTACT

034 686202746; rafabravomarques@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Specialist, Department of Cardiology, Hospital Costa del Sol, Marbella (Malaga,) Spain

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

ES (10)