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临床试验/NCT04432194
NCT04432194Unknown不适用

Evaluation of the Effect of Nutritional Supplementation and Pulmonary Rehabilitation on the Clinical Status of Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Instituto Nacional de Enfermedades Respiratorias2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over pulmonary function

研究概览

简要总结

Cardiovascular diseases (CVD) are the leading cause of death in the world and our country. The prevalence of Heart Failure (HF) is 1-2% in the adult population in developed countries, up to 10% among people 70 years of age. Concerning COPD, it is estimated that by 2030 will be the third leading cause of death in the world; the prevalence in Mexico is 18.4%. Also, according to INEGI data, it is the 5th cause of death in people over 65.

50% of patients with COPD die of cardiovascular causes, and they are at higher risk of developing HF, hospital readmissions, and death.

Subjects with HF and COPD concomitant have alterations such as; systemic inflammation, loss of muscle mass and strength of both skeletal and respiratory muscles, reduced tolerance to exercise, and lung function, which has an important impact on clinical status, quality of life and prognosis.

The objective of nutritional treatment in HF is to reduce heart overload and reduce cardiovascular risk. On the other hand, in COPD, it is to improve lung function. However, this is not enough to maintain the protein reserves of patients due to previously affected factors. Therefore, it is vitally essential to contemplate the supplementation with amino acids that prevent and delay the loss of protein reserves, as well as the delay in clinical status.

The β-hydroxy-β-methyl butyrate (HMB) is a metabolite of leucine, with an anticatabolic and anabolic effect. HMB improves the synthesis of proteins, muscle mass, strength, and muscle functionality. Citrulline has been associated with increased muscle mass, VO2, and exercise tolerance.

On the other hand, pulmonary rehabilitation (RP) has improved exercise tolerance, mass, and strength of skeletal and respiratory muscles, quality of life, reduction of hospitalizations, and mortality. However, in concomitant HF and COPD, there are no guidelines that specify the type of RP or if there is a synergistic effect with nutritional supplementation and its impact on clinical status.

详细描述

Heart Failure

Heart Failure (HF) is a complex syndrome consequence of any structural or functional abnormality that impairs the capacity of filling or ejected of the heart. (1, 2).

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a progressive, systemic, and multi-organic disease with structural and functional changes, mostly in the lungs. It is characterized by a progressive limitation of airflow as a response to external factors such as airflow contamination, smoking, biomass, which are associated with chronic inflammation. (3).

Epidemiology

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients that accept and signed the study consent.
  • > 40 years old
  • Patients with Heart failure diagnosis confirmed by echocardiographic criteria according to the European Society of Cardiology guidelines (2).
  • Heart failure patients in functional class I to III according to NYHA
  • Patients with Chronic Obstructive Pulmonary Disease diagnosis according to GOLD guidelines with a post-bronchodilator spirometry VEF1/FVC index <0.70 (50)

排除标准

  • Patients with recent (<3 months) exacerbations
  • Terminal Chronic Renal Kidney Disease with a creatinine clearance <30 ml/min/1.73m2
  • Patients with a cancer diagnosis
  • Patients with limitation to exercise
  • Patients enrolled in another study protocol

结局指标

主要结局

Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over pulmonary function

时间窗: Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

Change from baseline in pulmonary function assessed by spirometry test

Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over prognosis in COPD and HF patients

时间窗: Two years after treatment initiation

survival follow-up

Evaluate the effect of nutritional supplementation and pulmonary rehabilitation on the clinical status

时间窗: Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

Change from baseline in functional class assessed by NYHA

Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over the skeletal muscle mass

时间窗: Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

Change from baseline in the skeletal muscle mass assessed by bioelectrical impedance

To evaluate the effect of pulmonary rehabilitation and supplementation over muscle function in COPD and HF patients

时间窗: Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

Change from baseline in pulmonary function assessed by dinamometry test

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dulce González Islas, PhD

Researcher in Medical Sciences

Instituto Nacional de Enfermedades Respiratorias

研究点 (2)

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