Safety and Efficacy of High Protein Diet Versus Glomerular Filtration Rate (GFR) Based Protein Diet in Non-obese Advanced Heart Failure (HF) Patients With Renal Insufficiency: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Change from baseline muscle mass at 6 months
研究概览
简要总结
Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR) based protein intake in non-obese advanced HF patients will be assessed. In this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. Rehospitalization, quality of life, depression an inflammatory status are second endpoints.
详细描述
Patient examinations:
Baseline data will be gathered on demographic and clinical characteristics, medical history, treatments and medications. Before initiating intervention, individuals will be assessed for anemia and 25 (OH) D2 and electrolytes status. Any insufficiency or imbalance will be corrected by drug therapy or supplementation. At baseline and at all visits, half or one month intervals, routine laboratory tests for heart failure patients (including Complete blood count (CBC), electrolytes status, glucose, albumin, cholesterol, triglyceride, blood urea nitrogen (BUN), C-reactive Protein (CRP),creatinine, uric acid, ferritin, 25 (OH) D, B-type natriuretic peptide (BNP), thyroid function, Prealbumin, urine analysis), appetite status and anthropometric measurements (weight, Hip and waist circumference) will be performed. At baseline and by the end of month 6, body composition, muscle mass, hand grip strength, Short Physical Performance Battery (SPPB), plasma lactate and interleukin 6 (IL-6), GFR, depression status and quality of life will be assessed. Follow up duration will be one year for measuring readmission and mortality rate. If a study participant did not attend a visit, a staff of randomized clinical trial (RCT) center will attempt to reach her/him, her/his designated friend or family member by phone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced HF patients class III in New York Heart Association (NYHA) based on European Society of Cardiology (ESC) definition
- •Hand grip strength less than normal for age,
- •Age >18 years,
- •Glomerular filtration rate (GFR) 30-90,
- •BMI <30, muscle mass >2 standard deviations (SDs) below mean in individuals aged 18-39 y in the NHANES III cohort.
排除标准
- •Respiratory failure,
- •Ventilator dependence,
- •Dialysis treatment, and sepsis,
- •Open abdominal surgery within 6 weeks prior to enrolment,
- •Diseases or conditions that might change the calorie and macronutrients requirement.
研究组 & 干预措施
high protein intake
Study participants will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg Ideal Body Weight)
干预措施: protein intake (Other)
GFR based protein intake
Study participants will receive GFR based protein diet to preserve renal function.
干预措施: protein intake (Other)
结局指标
主要结局
Change from baseline muscle mass at 6 months
时间窗: At baseline and after 6 months
muscle mass will be assessed by Dual-Energy X-Ray Absorptiometry (DEXA)
次要结局
- Change from baseline quality of life status at 6 months(AT baseline and after 6 months)
- Change from baseline appetite status at 6 months(At baseline, in each visit up to 6 months)
- Change from baseline kidney function at 6 months(At baseline and after 6 months)
- Rehospitalization(Number of hospital admission will be recorded from date of intervention initiation until 1 year)
- Change from baseline handgrip strength at 6 months(At baseline and after 6 months)
- Change from baseline depression status at 6 months(At Baseline and after 6 months)
- Mortality rate(Up to 1 year)
- Change from baseline physical performance at 6 months(At baseline and after 6 months)