Pulmonary Hypertension Clinical Trial
Official title:
Latin American Pulmonary Hypertension Registry
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.
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.
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