CClinicalTrials.gg
Status unknownNCT05600218RAMPHAUpdated Nov 7, 2022

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

An observational study in Pulmonary Arterial Hypertension, sponsored by Hospital Costa del Sol. Status unknown at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.

Sponsored by Hospital Costa del Sol · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Pulmonary Arterial Hypertension
  • Selexipag
  • Real World Data
  • Effectiveness
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Hospital Costa del Sol is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Decline to participate in the study
  • Patients living 6 months or less in the reference health area
  • Patients with active malignant tumors
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
60 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • DrugNo intervention - Observational study

    Real life drug evaluation

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Risk stratification variables

    Percentage of clinical tests that have been used to include study treatment.

    Time frame: Basaline

  2. Events

    Incidence of events in follow-up: admission for worsening pulmonary hypertension; need for systemic prostacyclins; unscheduled admission for any cause; death related to pulmonary hypertension; death from any cause.

    Time frame: 12 months

07

Study locations

10 of 10 sites recruiting
  • Hospital de Poniente
    El Ejido, Almería, Spain
    • Joaquín Vizcaíno Ricoma · Contact
    • Joaquín Vizcaíno Ricoma · Principal investigator
    Recruiting
  • Hospital San Juan de la Cruz
    Úbeda, Jaén, Spain
    • Bonilla Palomas Bonilla Palomas · Contact
    • Juan Luis Bonilla Palomas · Principal investigator
    Recruiting
  • Hospital Costa del Sol
    Marbella, Málaga, Spain
    • Rafael Bravo Marques · Contact
    • Rafael Bravo Marques · Principal investigator
    Recruiting
  • Hospital Clinico Universitario San Cecilio
    Granada, Spain
    • Juan Luis Calleja Rubio · Contact
    • Juan Luis Calleja Rubio · Principal investigator
    Recruiting
  • Hospital Juan Ramón Jiménez
    Huelva, Spain
    • José Morgado García de Polavieja · Contact
    • José Morgado García de Polavieja · Principal investigator
    • Ignacio Martín Suárez · Sub investigator
    Recruiting
  • Hospital Regional de Malaga
    Málaga, Spain
    • Francisco Espíldora Hernández · Contact
    • Francisco Espíldora Hernández · Principal investigator
    Recruiting
  • Hospital Universitario Virgen de la Victoria
    Málaga, Spain
    • Víctor Becerra Muñoz · Contact
    • Víctor Manuel Becerra Muñoz · Principal investigator
    Recruiting
  • Hospital Universitario de Valme
    Sevilla, Spain
    • Irene María Estrada Parra · Contact
    • Irene María Estrada Parra · Principal investigator
    Recruiting
  • Hospital Universitario Virgen del Rocío
    Sevilla, Spain
    • Amadeo Wals Rodríguez · Contact
    • Amadeo Wals Rodríguez · Principal investigator
    Recruiting
  • Hospital Universitario Virgen Macarena
    Sevilla, Spain
    • Alejandro Recio Mayoral · Contact
    • Alejandro Recio Mayoral · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Once the database has been completed and the main results article has been published, access to the database through a free repository (e.g. Mendeley) will be considered.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05600218
Lead sponsor
Hospital Costa del Sol
Collaborators
Hospital Universitario Virgen Macarena, Hospital Regional de Malaga, Hospital Universitario Virgen de la Victoria, Hospital San Juan de la Cruz, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Hospitales Universitarios Virgen del Rocío, Hospital Clinico Universitario San Cecilio, Hospital Universitario de Valme, Hospital de Poniente
Responsible party
Rafael Bravo Marqués (Medical Specialist, Department of Cardiology, Hospital Costa del Sol, Marbella (Malaga,) Spain, Hospital Costa del Sol) — Principal investigator
First posted
Oct 31, 2022
Start date
Jun 1, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 7, 2022

Study contacts

Rafael Bravo Marqués, PhD, MD
Contact
rafabravomarques@gmail.com
034 686202746

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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