Clinical trial NCT03213821: Safety and Efficacy of High Protein Diet Versus GFR Based Protein Diet in Heart Failure Patients With Renal Insufficiency
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Renal Insufficiency
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study design A randomized, parallel-arm, controlled pilot study is designed. Sample size is determined 50 participants per treatment arm using the stepped rules of thumb, with standardized effect sizes of 0.1 or less and power 80% for main trial (n=100). After baseline assessments, balanced permuted block method will be used for randomization. Concealment of the randomization sequence will be performed by the RCT center of Rajaie Cardiovascular, Medical and Research Center. Intervention will be according to the randomization sequence.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline muscle mass at 6 months
timeFrame: At baseline and after 6 months
Secondary outcomes:
measure: Change from baseline depression status at 6 months
timeFrame: At Baseline and after 6 months
measure: Change from baseline appetite status at 6 months
timeFrame: At baseline, in each visit up to 6 months
measure: Change from baseline quality of life status at 6 months
timeFrame: AT baseline and after 6 months
measure: Mortality rate
timeFrame: Up to 1 year
measure: Rehospitalization
timeFrame: Number of hospital admission will be recorded from date of intervention initiation until 1 year
measure: Change from baseline kidney function at 6 months
timeFrame: At baseline and after 6 months
measure: Change from baseline handgrip strength at 6 months
timeFrame: At baseline and after 6 months
measure: Change from baseline physical performance at 6 months
timeFrame: At baseline and after 6 months
Other outcomes:
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