Pulmonary Hypertension Modality of Death and Validation of REVEAL Risk Score

NCT04677608 | Unknown

• 1 other identifier: ASPYRE-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary Arterial Hypertension (PAH) is a chronic disease characterized by a progressive increase in pulmonary vascular resistance (PVR), which leads to right ventricular (RV) failure, and ultimately death. Different studies have outlined how various factors as vascular resistance, functional class, age, correlate with mortality. However, the modality of death and risk factors for mortality in patients with PAH are little known. For this purpose, more studies are necessary to analyze the risk factors related to modality of death in PAH.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Modality of death

  to identify the different modality of death in patients with PAH

  two years

• Risk factors

  to identify risk factors for mortality in patients with PAH

  two years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with a confirmed diagnosis of Pulmonary Hypertension (PH) by Right Heart Catheterization (RHC), according to pre-capillary pulmonary hypertension (mPAP ≥ 25mmHg, PCWP ≤15 mmHg, PVR \> 3 WU)

You may qualify if:

• Diagnosis of PAH (group 1) according to ESC/ERS classification

You may not qualify if:

• Diagnosis of one of the following groups of PH:
• Group 1: PAH associated with congenital heart disease
• Group 2: PH due to left heart disease
• Group 3: PH due to lung disease and/or hypoxia
• Group 4: Chronic Thromboembolic PH (CTEPH)
• Group 5: PH due to miscellaneous causes

Sponsors & Collaborators

• iPHNET (italian Pulmonary Hypertension NETwork): lead

Study Sites (1)

Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Carmine Dario Vizza, MD

CONTACT

+39 3358307644; dario.vizza@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: July 21, 2020
• Primary Completion: April 30, 2021
• Study Completion: August 31, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

IT (1)