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临床试验/NCT02252705
NCT02252705已完成不适用

Mexican Registry of Pulmonary Hypertension

Remehip0 个研究点目标入组 875 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
875
主要终点
Major adverse cardiovascular events

研究概览

简要总结

Prospective multicenter registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and four years follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population with well characterized Pulmonary Hypertension.

详细描述

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.

Variables to be included. In all patients: a) date of onset of symptoms, b) medical history, c) personal and family 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 11, 12, l) biomarkers: troponin I (TnI), brain natriuretic peptide (BNP), D - dimer (DD), INR, n) current treatment, o) in-hospital and follow - up outcome, p) MACE.

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, when possible or feasible; in patients under oral anticoagulation INR 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.

Sites. In centers (outcome treatment and tertiary center), investigators with expertise and experience in diagnosis, stratification and treatment of patients with PH will be involved. Centers without expertise, but with facilities to diagnosis, stratification (six-minute walk distance, pulmonary function tests, V/Q lung scan and or pulmonary angiography, right heart catheterization, and biomarkers) will be included too, as long as they adhere to protocol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 2 years with: a) diagnosis of PH (PAH by RHC), b) Groups I and IV

排除标准

  • Severe pulmonary function abnormalities (vital capacity < 60% predicted, FEV1 < 50% predicted)
  • Abnormal pulmonary capillary wedge pressure (> 15 mmHg)
  • Refusal to participate.

结局指标

主要结局

Major adverse cardiovascular events

时间窗: 4 years

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

次要结局

  • Cardiovascular death(4 years)

研究者

发起方
Remehip
申办方类型
Other
责任方
Sponsor

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