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NCT05600218 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— RAMPHA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date November 2022
Source Hospital Costa del Sol
Contact Rafael Bravo Marqués, PhD, MD
Phone 034 686202746
Email rafabravomarques@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• No intervention - Observational study
Real life drug evaluation

Locations
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

Sponsors (10)
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

Country where clinical trial is conducted

Spain, 

Outcome
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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