NCT03213821

Safety and Efficacy of High Protein Diet Versus GFR Based Protein Diet in Heart Failure Patients With Renal Insufficiency

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rajaie Cardiovascular Medical and Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure With Reduced Ejection Fraction
• Renal Insufficiency

Interventions

Type	Name	Description
OTHER	protein intake	For each participant, weighed food records of 3 consecutive days will be analyzed for estimation of calorie and macronutrient intake and dietary preferences. To make sure good compliance, diets will be developed regarding patient's dietary habits and preferences individually. High calorie (30-35 kcal/kg Ideal body weight) diets including 6-8 small meals will be formulated. Intervention group will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg IBW). Comparison group will receive protein based on GFR to preserve renal function. For older adults (\>65 years) protein content of diet will be as recommended by the international study group to review dietary protein needs with aging (PROT-AGE). In subjects with lower intake of protein, carbohydrate will be substituted. Both group will receive low fat diet.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-11-30
• Completion: 2019-12-30
• First posted: 2017-07-11
• Last updated: 2017-07-11