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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: protein intake

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high protein intake; Study participants will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg Ideal Body Weight)	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.
Active Comparator: GFR based protein intake; Study participants will receive GFR based protein diet to preserve renal function.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline muscle mass at 6 months	muscle mass will be assessed by Dual-Energy X-Ray Absorptiometry (DEXA)	At baseline and after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline depression status at 6 months	Cardiac Depression Scale (CDS) questionnaire	At Baseline and after 6 months
Change from baseline appetite status at 6 months	Simplified Nutritional Appetite Questionnaire (SNAQ)	At baseline, in each visit up to 6 months
Change from baseline quality of life status at 6 months	Kansas City Cardiomyopathy Questionnaire	AT baseline and after 6 months
Mortality rate	Mortality occurrence	Up to 1 year
Rehospitalization	Frequency of hospital admission in 1 year	Number of hospital admission will be recorded from date of intervention initiation until 1 year
Change from baseline kidney function at 6 months	Glomerular filtration rate (GFR) (WIZARD® Automatic Gamma Counter) will be performed	At baseline and after 6 months
Change from baseline handgrip strength at 6 months	Handgrip strength will be measured using hand grip dynamometer	At baseline and after 6 months
Change from baseline physical performance at 6 months	SPPB score will be measured for physical performance assessment which includes: gait speed (timed 4-metre walk), sit-to-stand time (timed test of five chair rises), and standing balance (side-by-side stand, tandem and semi-tandem positions)	At baseline and after 6 months

Collaborators and Investigators

• Sponsor: Rajaie Cardiovascular Medical and Research Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Heart Failure; Renal Insufficiency
• Other Study ID Numbers: 96001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No