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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Costa del Sol

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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