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

Renal Insufficiency Clinical Trial

— GFR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03213821
• Other study ID #: 96001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: July 10, 2017
• Start date: November 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2017
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline depression status at 6 months	Cardiac Depression Scale (CDS) questionnaire	At Baseline and after 6 months
Secondary	Change from baseline appetite status at 6 months	Simplified Nutritional Appetite Questionnaire (SNAQ)	At baseline, in each visit up to 6 months
Secondary	Change from baseline quality of life status at 6 months	Kansas City Cardiomyopathy Questionnaire	AT baseline and after 6 months
Secondary	Mortality rate	Mortality occurrence	Up to 1 year
Secondary	Rehospitalization	Frequency of hospital admission in 1 year	Number of hospital admission will be recorded from date of intervention initiation until 1 year
Secondary	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
Secondary	Change from baseline handgrip strength at 6 months	Handgrip strength will be measured using hand grip dynamometer	At baseline and after 6 months
Secondary	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