Multimodal Approach of Undernutrition in Chronic Heart Failure : a Controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ventilatory workload VO2
研究概览
简要总结
The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an independent risk factor for mortality and complications. Up-to-date, interventional studies involving nutrition are scarce in CHF. Academic societies are recommending the use of oral nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS could improve nutritional status in undernourished CHF patients, but solely administered, have a limited impact on undernutrition, physical performance and prognosis. A multimodal approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the clinical benefits of such an approach in patients with chronic respiratory insufficiency (CRI), who have similar nutritional and muscular characteristics.
Exercise rehabilitation is well validated in CHF patients, but has never been validated in case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality of life and cardiovascular outcomes including mortality.
N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be useful for CHF patients rehabilitation.
Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly muscle strength, walking endurance and quality of life. In the context of a multimodal approach, Androgen substitution together with exercise rehabilitation and ONS could have a beneficial effect on muscle mass, strength and endurance of CHF patients, as already described in CRI, elderly and HIV patients.
The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF patients.
详细描述
Study aims :
Main study aim :
To evaluate the impact of a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS on exercise capacity of undernourished CHF patients.
Secondary study aims :
To Evaluate the impact of the 3-month multimodal approach on :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable patients with CHF, defined by the absence of acute episodes since 2 months, and absence of exercise rehabilitation in the two last months
- •NYHA III Heart failure
- •VO2 peak < 18 ml/kg/min
- •Left ventricle ejection fraction ≤ 40%
- •Age ≥ 18 years, informed, having given their consent
- •Absence of acute disease
- •Undernutrition, defined by :
- •Involuntary weight loss ≥5% during the 12 last months, without any increase of diuretics doses
- •or body mass index <20
- •or fat-free mass index assessed by BIA <18 in men, and <15 in women.
排除标准
- •Heart failure related to pulmonary hypertension
- •Heart failure treatable by surgery or angioplasty
- •Patients eligible to ventricular resynchronisation
- •Instable heart failure
- •Patients waiting for transplantation
- •On-going imunosuppressant or corticosteroids
- •Disease affecting 6-month survival (end-stage cancer, or chronic disease,...)
- •Positive VIH or hepatitis C serology
- •Liver failure
- •Respiratory insufficiency
- •End-stage (stage 5) renal failure (creatinine clearance ≤15ml/kg/min)
- •Acute disease
- •Previous history of hormonal cancer (breast, prostate)
- •Suspected or proved hormonal cancer (breast, prostate)
- •Hypersensibility to testosterone or components of testosterone patch
- •Liver tumor or previous history of liver tumor
- •Unability or contra-indication to rehabilitation program (defined by the French society of Cardiology including contra-indication to physical exercise)
- •Orthopedical limitations to exercise
- •Type 2 diabetes requiring insulin since less than 3 months
- •Patients having not giving their consent
结局指标
主要结局
ventilatory workload VO2
时间窗: 3 months
次要结局
- Heart function (to measure left ventricle fraction)(at 3 months)
- Heart function (clinical exam)(at 6 months)
- Heart function (plasma NT pro-Brain Natriuretic Peptide)(at 3 months)
- Plasma NT pro-Brain Natriuretic Peptide (Nt ProBNP)(at 3 months and at 6 months)
- Maximal cycle exercise capacity test coupled with respiratory exchanges: VO2 peak, peak workload on bicycle, endurance time between peak and ventilatory workload(at 3 months)
- Quadriceps strength(at 3 months)
- 6-min walking test(at 3 months)
- Nutritional status (weight, height, body mass index)(before intervention and at 3 months and 6 months)
- Quality of life with specific questionnaires(before intervention and at 3 months and 6 months)
- Hospital stays (number of days)(at 12 months and at 15 months)
- Body composition (weight, height, body mass index)(at month 3 and month 6)