Heart Failure With Reduced Ejection Fraction, Renal Insufficiency
Conditions
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.
Interventions
OTHERprotein 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.
Sponsors
Rajaie Cardiovascular Medical and Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline muscle mass at 6 months | At baseline and after 6 months | muscle mass will be assessed by Dual-Energy X-Ray Absorptiometry (DEXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline appetite status at 6 months | At baseline, in each visit up to 6 months | Simplified Nutritional Appetite Questionnaire (SNAQ) |
| Change from baseline quality of life status at 6 months | AT baseline and after 6 months | Kansas City Cardiomyopathy Questionnaire |
| Mortality rate | Up to 1 year | Mortality occurrence |
| Change from baseline depression status at 6 months | At Baseline and after 6 months | Cardiac Depression Scale (CDS) questionnaire |
| Change from baseline kidney function at 6 months | At baseline and after 6 months | Glomerular filtration rate (GFR) (WIZARD® Automatic Gamma Counter) will be performed |
| Change from baseline handgrip strength at 6 months | At baseline and after 6 months | Handgrip strength will be measured using hand grip dynamometer |
| Change from baseline physical performance at 6 months | At baseline and after 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) |
| Rehospitalization | Number of hospital admission will be recorded from date of intervention initiation until 1 year | Frequency of hospital admission in 1 year |
Outcome results
None listed