Pulmonary Arterial HypertensionRAMPHANCT05600218
RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
An observational study of Pulmonary Arterial Hypertension, run by Hospital Costa del Sol at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 60 participants
- Where
- 10 sitesSpain
- Study dates
- 1 Jun 2021to 31 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary arterial hypertension (mostly intermediate risk patients) who are started on treatment with Selexipag according to clinical practice guideline recommendations.
Who may be able to join
- They agree to participate in the study by signing an informed consent form
Who cannot join
- Decline to participate in the study
- Patients living 6 months or less in the reference health area
- Patients with active malignant tumors
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Hospital de Poniente
El Ejido, Almería
Joaquín Vizcaíno Ricoma
Joaquín Vizcaíno Ricoma
- Recruiting
Hospital Clinico Universitario San Cecilio
Granada
Juan Luis Calleja Rubio
Juan Luis Calleja Rubio
- Recruiting
Hospital Juan Ramón Jiménez
Huelva
José Morgado García de Polavieja
José Morgado García de Polavieja
- Recruiting
Hospital Regional de Malaga
Málaga
Francisco Espíldora Hernández
Francisco Espíldora Hernández
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Víctor Becerra Muñoz
Víctor Manuel Becerra Muñoz
- Recruiting
Hospital Costa del Sol
Marbella, Málaga
Rafael Bravo Marques
Rafael Bravo Marques
- Recruiting
Hospital Universitario de Valme
Seville
Irene María Estrada Parra
Irene María Estrada Parra
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Amadeo Wals Rodríguez
Amadeo Wals Rodríguez
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Alejandro Recio Mayoral
Alejandro Recio Mayoral
- Recruiting
Hospital San Juan de la Cruz
Úbeda, Jaén
Bonilla Palomas Bonilla Palomas
Juan Luis Bonilla Palomas
About this study
Official title: 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
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- No intervention - Observational study
- Keywords
- Pulmonary Arterial Hypertension, Selexipag, Real World Data, Effectiveness
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - Observational studyDrug
Real life drug evaluation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: No intervention - Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement (risk profile)
Percentage of patients reducing annual mortality risk profile according to ESC/ERS Clinical Practice Guidelines 2015 Risk Stratification.
Measured: 12 months
Secondary outcomes (2)
Risk stratification variables
Percentage of clinical tests that have been used to include study treatment.
Measured: Basaline
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Costa del Sol
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Rafael Bravo Marqués, Hospital Costa del Sol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600218
- Sponsor's protocol ID
- 0991-N-21
- Acronym
- RAMPHA
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
- ClinicalTrials.gov ID
- NCT05600218
- Acronym / sponsor ID
- RAMPHA / 0991-N-21
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, Selexipag, Real World Data, Effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Costa del SolUniversity, hospital or other
- 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
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: No intervention - Observational studyPatients with pulmonary arterial hypertension on treatment with prostacyclin IP receptor agonists because they are at intermediate risk of mortality at one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension (mostly intermediate risk patients) who are started on treatment with Selexipag according to clinical practice guideline recommendations.
Key inclusion criteria (1 listed)
- They agree to participate in the study by signing an informed consent form
Key exclusion criteria (3 listed)
- Decline to participate in the study
- Patients living 6 months or less in the reference health area
- Patients with active malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - Observational studyReal life drug evaluation | Drug | Cohort 1 |
Primary outcome
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.
2 secondary outcomes
Risk stratification variables
Time frame: Basaline
Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Hospital Costa del Sol at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Bravo Marqués, PhD, MD (034 686202746, rafabravomarques@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (risk profile) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.