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

NCT03213821 | Unknown DMC

• 1 other identifier: 96001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline depression status at 6 months

  At Baseline and after 6 months

• Change from baseline appetite status at 6 months

  At baseline, in each visit up to 6 months

• Change from baseline quality of life status at 6 months

  AT baseline and after 6 months

• Mortality rate

  Up to 1 year

• Rehospitalization

  Number of hospital admission will be recorded from date of intervention initiation until 1 year

Study Arms (2)

high protein intake

EXPERIMENTAL

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

GFR based protein intake

ACTIVE COMPARATOR

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

Other: protein intake

Interventions

protein intake OTHER

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.

GFR based protein intake; high protein intake

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajaie Cardiovascular Medical and Research Center: lead

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: July 11, 2017
• Study Start: November 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share