The crossover group will be further randomly assigned (1:1) with 20 patients in each group. The two crossover arms of the study will follow the patients for 8 weeks. At the end of week 8, all crossover patients will have a 1 week wash out period. Thereafter, patients will be crossed-over to the opposing arm of the study for an additional 1+8 weeks (R Drink 8 oz 3-5x/day versus a placebo drink 8 oz 3-5x/day).

The non-crossover group of the study will follow 20 patients for the entire 17 weeks and participants in this arm will not be crossed over, will not have a washout period, and will consume R Drink for the total duration of the study. If patients in this arm wish to continue on the R Drink, for 6 additional months they may do so. At the end of the optional 6 months these patients will have a repeat research transthoracic echocardiogram. Data collection will occur at baseline, week 8, and week 17. An additional 6 month data collection time point will occur for patients in the third arm opting to continue R Drink.

Heart Failure

R Drink is a dietary supplement drink containing filtered reverse osmosis water and 150 mg/L of both USP Grade calcium chloride and magnesium chloride, 10 mg/L Biotin (vitamin B7), 500 mg/L of Niacinamide (B3) and 550 mg/L of Choline.

R Drink

Ohio State University Wexner Medical Center

Dietary Supplementation in Heart Failure

Number of total hospital readmissions post-enrollment.

Additional functional assessment will be made by classifying patients into the appropriate New York Heart Association (NYHA) functional class. NYHA HF classification is a clinical assessment based on reported limitations and symptoms and is assigned by medical professionals performing the assessment. NYHA classification is considered a routine component of HF assessment.

The echo exam will include the assessment of systolic and diastolic function by recommended techniques (left atrial volume/index, doppler mitral inflow velocities, E/A ratio, tissue doppler of mitral valve, E/e' ratio, IVRT, RVSP, DT, global function/LVEF, left ventricular cavity size, 2D biplane simpson, LV volume/mass). Measurements of these parameters are considered part of a routine clinical echocardiographic exam, but will be completed as part of the research study.

Quality of life will be assessed with the Minnesota Living with Heart Failure Questionnaire (MLWFQ), which has been validated as tool to measure quality of life. The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. Thus, scores may range from 0 (zero) to 105, where a lower score is indicative of a better quality of life.

The 6-minute walk test (6MWT) is a practical and simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. It measures the distance that a patient can quickly walk on a flat, hard surface over 6 minutes. It importantly evaluates the global responses in multiple systems involved in exercise, such as the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular system and metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity, but since most activities of daily living are performed at submaximal levels of exertion, the 6MW distance may better reflect the functional exercise level for daily physical activities.

B-natriuretic peptide (BNP) and NT-proBNP are serological markers of HF measured in pg/mL.

(eGFR) measure in mL/min per 1.73 m2 and creatinine levels. The Estimated glomerular filtration rate is the best test to measure your level of kidney function and determine your stage of kidney disease. A doctor can calculate it from the results of your blood creatinine test measured mg/dL, your age, body size and gender.

C-reactive protein is a surrogate marker of inflammation measured in mg/L.

lipid panel measures total cholesterol and triglycerides in mg/dL.

Hemoglobin A1c reflects a serum glucose over a 3-month time frame will be measured as a percentage.

William Abraham

Professor of Medicine, Physiology, and Cell Biology Chair of Excellence in Cardiovascular Medicine Director, Division of Cardiovascular Medicine Deputy Director, Davis Heart and Lung Research Institute

biotin/tūska

Dietary Supplementation in Heart Failure

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