RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists (RAMPHA)

November 2, 2022 updated by: Rafael Bravo Marqués, Hospital Costa del Sol

Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Real life drug evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement (risk profile)
Time Frame: 12 months
Percentage of patients reducing annual mortality risk profile according to ESC/ERS Clinical Practice Guidelines 2015 Risk Stratification.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk stratification variables
Time Frame: Basaline
Percentage of clinical tests that have been used to include study treatment.
Basaline
Events
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Costa del Sol

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0991-N-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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