An interventional study of R Drink in Heart Failure, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
A single-center, double-blind, placebo-controlled, cross-over study pilot study comparing R Drink vs. placebo in 60 heart failure patients. Half of the participants will also have diabetes mellitus. The 60 patients will be distributed among three arms. Total distance walked in six minutes and hospital readmission rates will be examined. Eligible heart failure patients include those with systolic or diastolic heart failure and diabetes mellitus can be Type I or II. All patients will continue on their standard heart failure and diabetes therapies while they participate in the study.
Heart failure (HF) affects millions of Americans, with approximately five-hundred thousand new cases diagnosed annually, with 40% or more of patients having a concomitant diagnosis of diabetes or prediabetes. HF is not a diagnosis itself, but rather a constellation of signs and symptoms due to impaired ventricular filling or ejection of blood. Some of the most common symptoms associated with heart failure include dyspnea, impaired exercise tolerance, and lower extremity edema. Certain co-morbidities like hypertension (HTN) and DM are found more commonly in conjunction with HF. In fact, diabetes is an independent predictor of heart failure. Patients with heart failure and diabetes can have additional clinical symptoms of peripheral neuropathy and poor wound healing, often leading to foot ulcers. The mainstay of treatment for HF at present, employs the use of goal directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT).
Despite these treatments, HF still accounts for over 20% of all hospital admissions in people older than 65. The estimated cost for HF admissions in the US is over $35 billion.
In limited case study, testing participants with a variety of chronic diseases, including HF and DM, observations suggest the incorporation of a dietary supplement drink (R 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 may be beneficial, which is the goal of this unique three-arm clinical trial.
These ingredients are Generally Recognized as Safe (GRAS) ingredients by the FDA and have multiple proposed mechanisms of action which include improved circulation and enhancing clearance of metabolic waste. These electronutrients play a role in the regulation of acetylcholine induced endothelium-dependent relaxation and regulation of nitric oxide, directly influencing vascular tone. They are involved in the s-adenosylmethionine and myelin pathways of the central nervous system, and promote the repair and protection of myelin which is essential for nerve conduction. These electronutrients may promote activation of adenosine triphosphate (ATP) which improves muscular contractions and nerve-muscle impulse transmission. Finally, by regulating the release of serum free fatty acid release, these specific electronutrients may assist in insulin regulation.
This pilot study will be a single center, double-blind, placebo controlled, cross-over study having three arms with a total of 60 patients - all with HF and half with DM - and will compare R Drink versus placebo on the distance walked in 6 minutes, and hospital readmission rates. Eligible patients will have a known diagnosis of HF (diastolic - HFpEF or systolic - HFrEF) classified as NYHA I-IV, a known diagnosis of DM (type I or type II) and will be selected from a larger population being followed in the Heart Failure Clinic at the Ohio State University Wexner Medical Center. All patients will continue on the standard HF and DM therapies as guided by their treating physician. Enrolled patients will be randomly assigned (2:1) to a crossover group (40 patients) and a non-crossover group (20 patients). 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 third arm 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.
At the end of study participation, all patients in the two arms that cross will have the study drink discontinued and will continue to follow standard heart failure and diabetic therapies as guided by their treating physicians. The study will use a permuted block randomization. This design should result in a balance of known and unknown con-founders and prevent identification of the randomization sequence, minimizing potential selection bias due to investigator preference. The groups should have the same baseline characteristics and be evenly distributed. Each of the 20 patient cohorts should enroll 10 patients with diabetes within each cohort.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 10 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Exclusion Criteria:
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).
Dietary Supplement: R Drink
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.
Dietary Supplement: R Drink
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.
Hospital Readmission Rates
Number of total hospital readmissions post-enrollment.
Time frame: Day 119
New York Heart Association Functional Class
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.
Time frame: Day 0, Day 119
Echocardiographic Measurements
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.
Time frame: Day 0, Day 56, Day 119
Quality of Life Questionnaires
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.
Time frame: Day 0, Day 56, Day 119
6-Minute Walk Test
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.
Time frame: Day 0, Day 56, and Day 119
Serological Assessment
B-natriuretic peptide (BNP) and NT-proBNP are serological markers of HF measured in pg/mL.
Time frame: Day 0, Day 56, and Day 119
Serological Assessment
(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.
Time frame: Day 0, Day 56, and Day 119
Serological Assessment
C-reactive protein is a surrogate marker of inflammation measured in mg/L.
Time frame: Day 0, Day 56, and Day 119
Serological Assessment
lipid panel measures total cholesterol and triglycerides in mg/dL.
Time frame: Day 0, Day 56, and Day 119
Serological Assessment
Hemoglobin A1c reflects a serum glucose over a 3-month time frame will be measured as a percentage.
Time frame: Day 0, and Day 119
Plan to share: Undecided
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