Renal Insufficiency Clinical Trial
Official title:
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
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.
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.
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