Pulmonary Arterial Hypertension Clinical Trial
— RAMPHAOfficial title:
Real World Andalusian Multicenter Data on Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists
| NCT number | NCT05600218 |
| Other study ID # | 0991-N-21 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2021 |
| Est. completion date | December 31, 2024 |
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
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital de Poniente | El Ejido | Almería |
| Spain | Hospital Clinico Universitario San Cecilio | Granada | |
| Spain | Hospital Juan Ramón Jiménez | Huelva | |
| Spain | Hospital Regional de Malaga | Málaga | |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
| Spain | Hospital Costa del Sol | Marbella | Málaga |
| Spain | Hospital Universitario de Valme | Sevilla | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital San Juan de la Cruz | Úbeda | Jaén |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Costa del Sol | Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Hospital Clinico Universitario San Cecilio, Hospital de Poniente, Hospital Regional de Malaga, Hospital San Juan de la Cruz, Hospital Universitario de Valme, Hospital Universitario Virgen de la Victoria, Hospital Universitario Virgen Macarena, Hospitales Universitarios Virgen del Rocío |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Risk stratification variables | Percentage of clinical tests that have been used to include study treatment. | Basaline | |
| Secondary | 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. | 12 months |
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