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临床试验/NCT01736137
NCT01736137已完成不适用

Evaluation of the Six Minute Walk Test, Heart Rate Variability and Quality of Life in Heart Failure Patients on Beta-blocker Treatment

Federal University of Uberlandia1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年11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
17
试验地点
1
主要终点
Maximum distance walked

研究概览

简要总结

The purpose of this study is to assess functional capacity, quality of life and functioning of the autonomic nervous system in heart failure patients on beta-blocker treatment. The study hypothesis is that subjects who walk less distance, have lower quality of life and reduced heart rate variability during the six minute walk test.

详细描述

Heart failure and its treatment result in symptoms such as pulmonary or systemic congestion causing impairment to the effort, psychological and social commitment, and impact on quality of life.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes
  • Different etiologies of Heart Failure
  • Functional class I - III (NYHA)
  • Left ventricular ejection fraction (LVEF) ≤ 50%
  • No history of previous cardiac surgery
  • In return for medical evaluation at the Amelio Marques Clinic, Hospital de Clinicas, Federal University of Uberlândia scheduled for the period from October 2012 to January 2013
  • Clinical stability observed by: heart rate, respiratory rate, blood pressure and arterial oxygen saturation

排除标准

  • Bad cognition compromising the understanding of tests
  • Physical disability that compromise the performance in walk test
  • Aortic aneurysm or any aortic deformity
  • Patients with signs or symptoms of transient myocardial ischemia with angina pectoris and/or class IV by the Canadian Cardiovascular Society Classification
  • Anomalous pressure behavior with hypertension > 180/100 mmHg
  • Orthostatic hypotension (decrease > 15 mmHg ) with symptoms
  • Arrhythmia with presence of complex ventricular extra systoles
  • Tachycardia sinus at rest (HR > 120 beats/min)
  • Atrioventricular block of 2nd or 3rd degree
  • Subjects with pacemakers or implantable cardioverter-defibrillator (ICD)
  • Functional class IV by the New York Heart Association
  • Chronic organ dysfunction such as renal failure, respiratory or liver disease
  • Active neoplasia over the past five years
  • Commitment as general weakness, fever, other limiting factors (psychological, musculoskeletal)
  • Feeling sick before the beginning of the Six minute walk test: intolerable angina or dyspnea, cramps in legs, staggering gait, excessive sweating (diaphoresis), pallor or ashen skin or SpO2 below 85%
  • Voluntary desire of the patient to withdraw from research

结局指标

主要结局

Maximum distance walked

时间窗: During six minute walk test

The six minute walk test will be performed twice by each patient, at the same day. The collection period will extend until the sample is complete. This is an observational study because there is no follow up and reassessment of patients.

次要结局

未报告次要终点

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Débora Lara Zuza Scheucher

Physiotherapist

Federal University of Uberlandia

研究点 (1)

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