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

Rajaie Cardiovascular Medical and Research Center

Status: Unknown

Conditions: Renal Insufficiency; Heart Failure With Reduced Ejection Fraction

Treatments: Other: protein intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03213821

96001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

high protein intake

Experimental group

Description:

Study participants will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg Ideal Body Weight)

Treatment:

Other: protein intake

GFR based protein intake

Active Comparator group

Description:

Study participants will receive GFR based protein diet to preserve renal function.

Treatment:

Other: protein intake