Latin American Pulmonary Hypertension Registry

NCT02570737 | Unknown

• 1 other identifier: Cardioneumology
• Study Type: observational
• Target: 500
• Locations: 8 countries
• Sites: 8

Brief Summary

The RELAHP registry is a Latin-American multinational, multicenter, prospective observational registry-type cohort study, which pretends to identify clinical characteristics, clinical course, management and outcome of all forms of pulmonary hypertension (PH). All consecutively consented patients newly diagnosed with WHO Group I-V PH according to specific hemodynamic criteria on right heart catheterization at the participating centers will be enrolled. Patients will be followed six-monthly for a minimum of five years from the time of enrollment.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  n-hospital or outpatient heart failure, cardiogenic shock, syncope, cardiovascular death and bleeding complications.

  5 years (Patients will be followed six-monthly for a minimum of five years)

Secondary Outcomes (1)

• Cardiovascular death

  5 years

Study Arms (2)

Incident patients

Patients with less than three months from diagnosis to start of the Registry or those who have been diagnosed during the recruitment period.

Prevalent patients

Patients who have been diagnosed with more than three months from diagnosis to start of the Registry.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Latin American Patients of any age, with diagnosis of Pulmonary Hypertension from groups I-V confirmed by Right Heart Catheterization

You may qualify if:

• Patients at least 18 years old
• Patients with any Group of Pulmonary Hypertension according to OMS Clinical Clasification (PH by RHC)
• Informed consent

You may not qualify if:

• Severe pulmonary function abnormalities (vital capacity \< 60% predicted, FEV1 \< 50% predicted)
• Abnormal pulmonary capillary wedge pressure (\> 15 mmHg)
• Refusal to participate.
• Patients younger than 18 years old

Sponsors & Collaborators

• Asociacion Latinoamericana de Torax: lead
• Actelion: collaborator
• Bayer: collaborator
• Ferrer Internacional S.A.: collaborator

Study Sites (8)

Hospital Universitario, Fundación Favaloro

Buenos Aires, Argentina

Location

Hospital Clementino Fraga - Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

Location

Instituto Nacional del Tórax, Universidad de Chile

Santiago, Chile

Location

Clínica Cardio Vid

Medellín, Colombia

Location

Honduras Medical Center

Tegucigalpa, Honduras

Location

Instituto Nacional de Cardiologia "Dr. Ignacio Chavez"

Mexico City, Tlalpan, 14080, Mexico

Location

Hospital Maciel

Montevideo, Uruguay

Location

Hospital de Clínicas Caracas

Caracas, Venezuela

Location

Related Links

• Pulmonary Hypertension
• High Blood Pressure

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• TOMAS R. PULIDO, M.D.

  ASOCIACIÓN LATINOAMERICANA DE TORAX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Study Start: April 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: April 1, 2019
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

CO (1); UR (1); ME (1); AR (1); BR (1); HO (1); CL (1); VE (1)