Latin American Pulmonary Hypertension Registry

Pulmonary Hypertension Clinical Trial

— RELAHP  

Official title:

Latin American Pulmonary Hypertension Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02570737
• Other study ID #: Cardioneumology
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 6, 2015
• Last updated: January 23, 2017
• Start date: April 2014
• Est. completion date: April 2019

Study information

• Verified date: January 2017
• Source: Asociacion Latinoamericana de Torax
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Introduction. Pulmonary hypertension (PH) is a worldwide group of vascular diseases characterized by progressive increase in pulmonary vascular resistance and pulmonary arterial pressure with secondary vascular and right ventricular (RV) remodeling, RV dysfunction, heart failure syndromes and, finally, premature death. In developed countries significant medical advances have occurred in the last two decades including a more systematic assessment and availability of new therapeutic approaches. In addition, current registries had shown new data regarding epidemiology, demography, clinical presentation, treatment and prognosis. However, the evidence coming from developing countries is scarce and more information is necessary to identify current care in such populations. In the other hand, high quality clinical registries may help to understand if the knowledge coming from clinical trials is being properly applied and if their results are reproducible in day-to-day clinical practice. The results of the REMEHIP, a registry with one-year enrollment and four-year follow-up will hopefully broad the investigators knowledge about clinical profile, medical care, therapeutic trends and outcome in a Mexican population with well characterized PH. Data collection will not only set current practices in relation to the epidemiology, diagnostics and treatment of PH in Latin-American, but will also set the mark for future investigations.

RELAHP itself is property of the Department of Pulmonary Circulation at the Latin American Thoracic Association (ALAT) and the participating doctors are members of this department. The registry is sponsored by ALAT with additional funding from multiple sponsors (Bayer Health Care, Actelion/Biotoscana, Grupo Ferrer).

RELAHP´s main objective is to shed light on the epidemiologic characteristics and clinical presentation of patients presenting with PH in Latin America, thus helping to know population evolution, all this by gathering the information, collected by main centers that work with PH in the region, on a uniform database. The data will allow establishing proper strategies for an early detection of the disease and a rational, therapeutic approach. Patients with newly diagnosed PH confirmed by right heart catheterization will be eligible for inclusion in the registry. This registry does not provide a predetermined appointment system; instead, the patient's treating doctor - according to the patients needs - shall determine the frequency of visits. Nevertheless, the record of condition and patient evolution must be actualized every six months.

Variables to be included. In all patients: a) date of onset of symptoms, b) medical history, c) treatment at enrollment, d) physical examination, d) WHO function class, e) six-minute walk distance, f) ECG, g) chest x-ray, h) echocardiogram, i) pulmonary function tests, j) V/Q lung scan and or pulmonary angiography, and/or pulmonary angiotomography k) right heart catheterization, and whenever possible indicated acute vasodilator challenge l) Laboratory test o) in-hospital and follow - up outcome, p) MACE q)Diagnostic classification l)Treatment intervention m)drug therapy, n)surgical interventions.

Visit office. Data will be collected in the first outcome and update through each follow-up about expected PH symptoms, functional class (WHO), current treatment, dose, compliance, collateral effects and concomitant medication, weight, blood pressure, heart and respiratory rate, and biomarkers, will be recorded in each visit.

Visits will be according with the standard health care of each center, but in general they will be made at least one every six months.

Quality Criteria. Following criteria will be used to improve quality data: a) standardized definitions, data and reports; b) tools for fast feedback; c) meetings among principal investigators and steering committee, at least one per year; d) ethics procedures review; e) electronic, simple and accessible data collection; f) rigorous center selection based on investigators expertise and/or facilities resources); g) consecutive patients enrollment to obtain representative sample; h) random centers audit; i) centralized data and statistical analysis; j) report all data and consistent conclusion; and k) transparency of funds for any publication. Furthermore, the quality of this registry will also be measured by the number of publications and presentations in national and international meetings as has previously been done.

Statistics. Quantitative baseline and continuous variables will be expressed as percentages, mean, standard deviation, odds ratio and CI. Differences between two groups will be examined by Student's t test and for multiple comparisons analysis of variance or nonparametric test. To analyze variables X2 will be used by Fisher's test. Cox proportional risk multivariate model will assess the relationship between each of these variables.

Structure of RELAHP: Executive committee, Single Data Centers (PH centers), Data Control Group and Publishing Group.

RELAHP is a multicenter project with doctors being the sole owners of the data of each individual PH center, and only the consolidated results, which are anonymous, are property of ALAT, thus keeping patient confidentiality and privacy safe.

As of 2014, a total of 12 centers (to be expanded) will contribute data to the registry during the planned five-year study period.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: April 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients at least 18 years old

• Patients with any Group of Pulmonary Hypertension according to OMS Clinical Clasification (PH by RHC)

• Informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Argentina	Hospital Universitario, Fundación Favaloro	Buenos Aires
Brazil	Hospital Clementino Fraga - Universidade Federal do Rio de Janeiro	Rio de Janeiro
Chile	Instituto Nacional del Tórax, Universidad de Chile	Santiago
Colombia	Clínica Cardio Vid	Medellín
Honduras	Honduras Medical Center	Tegucigalpa
Mexico	Instituto Nacional de Cardiologia "Dr. Ignacio Chavez"	Mexico city	Tlalpan
Uruguay	Hospital Maciel	Montevideo
Venezuela	Hospital de Clínicas Caracas	Caracas

Sponsors (4)

Lead Sponsor	Collaborator
Asociacion Latinoamericana de Torax	Actelion, Bayer, Ferrer Internacional S.A.

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Honduras,  Mexico,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death	Secondary to right heart failure, cardiogenic shock, auricular or ventricular arrhythmia.	5 years

External Links

•   High Blood Pressure
•   Pulmonary Arterial Hypertension
•   Pulmonary Hypertension