Safety and Efficacy of High Protein Diet Versus GFR-based Protein Diet in Non-obese Advanced Heart Failure Patients with Renal Insufficiency: Randomized Controlled Trial Study Design

 Inadequate nutritional status has been linked to poor outcomes in heart failure patients. Generally, high protein intake is recommended for sarcopenic and malnourished patients. On the other hand, protein restriction is recommended in patients with renal damage. We found no clinical trial considering protein intake in HF patients with renal insufficiency.

 The present study is a randomized, parallel-arm, controlled pilot study. The effect of a high protein diet versus glomerular filtration rate (GFR)-based protein intake in non-obese advanced HF patients will be assessed. Muscle mass will be assessed as the main outcome. Re-hospitalization, quality of life, renal function, physical performance, appetite and mortality are the second outcomes.

 In the present clinical trial, for the first time, we will evaluate the effect of high protein diet in patients with advanced HF who have pre-existing renal impairment. The result of the present trial may shed light on the methods for the nutritional intervention in this group of patients.