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Dietary Supplementation in Heart Failure (R Drink)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03980574
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Vascular Scientific, LLC
Information provided by (Responsible Party):
William Abraham, Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure Dietary Supplement: R Drink

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Dietary Supplementation in Heart Failure
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Crossover Group
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
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.

Non-crossover Group
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.

Primary Outcome Measures :
  1. Hospital Readmission Rates [ Time Frame: Day 119 ]
    Number of total hospital readmissions post-enrollment.

Other Outcome Measures:
  1. New York Heart Association Functional Class [ Time Frame: Day 0, Day 119 ]
    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.

  2. Echocardiographic Measurements [ Time Frame: Day 0, Day 56, Day 119 ]
    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.

  3. Quality of Life Questionnaires [ Time Frame: Day 0, Day 56, Day 119 ]
    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.

  4. 6-Minute Walk Test [ Time Frame: Day 0, Day 56, and Day 119 ]
    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.

  5. Serological Assessment [ Time Frame: Day 0, Day 56, and Day 119 ]
    B-natriuretic peptide (BNP) and NT-proBNP are serological markers of HF measured in pg/mL.

  6. Serological Assessment [ Time Frame: Day 0, Day 56, and Day 119 ]
    (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.

  7. Serological Assessment [ Time Frame: Day 0, Day 56, and Day 119 ]
    C-reactive protein is a surrogate marker of inflammation measured in mg/L.

  8. Serological Assessment [ Time Frame: Day 0, Day 56, and Day 119 ]
    lipid panel measures total cholesterol and triglycerides in mg/dL.

  9. Serological Assessment [ Time Frame: Day 0, and Day 119 ]
    Hemoglobin A1c reflects a serum glucose over a 3-month time frame will be measured as a percentage.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from a pool of patients being treated in an ambulatory Heart Failure (HF) clinic. HF patients with both preserved and reduced ejection fractions will be considered. Half of the participants will have diabetes mellitus (DM). HF patients with DM Type I or II will be considered.

Inclusion Criteria:

  • Age ≥ 18 years old
  • Confirmed diagnosis of heart failure (NYHA Class I-IV) (all subjects)
  • Confirmed diagnosis of diabetes (type I or II) (only 30 subjects)
  • At least 3 months of standard, conventional drug therapy for heart failure, including diuretic dosing. Diuretics can be adjusted during the study per the treating physician within a relatively standard dosing scale. Overall medical therapy should be considered maximally tolerated appropriate therapy by the treating physician.
  • Ability to participate in 6-minute walk test
  • Literacy and ability to complete neuropathic pain and heart failure quality of life questionnaires
  • Signed written consent

Exclusion Criteria:

  • Contraindications to the consumption of 1L of purified water per day, when taken into consideration that the average patient with HF is recommended to adhere to a 1.5-2 L fluid restriction per day
  • Liver cirrhosis / Prior diagnosis of liver failure
  • End-stage renal disease requiring hemo/peritoneal dialysis
  • CHF admission requiring diuresis within 14 days prior to enrollment date
  • Systolic BP < 100 mmHg or diastolic BP < 60 mmHg (at time of randomization)
  • Blood glucose < 70 mg/dl (at time of randomization)
  • QRS duration > 130 ms
  • QTc duration > 480 ms
  • Prior diagnosis of moderate to severe COPD
  • Uncontrolled systemic systolic/diastolic hypertension (SBP > 160 mmHg or DBP > 100 mmHg)
  • Pregnancy
  • History of ventricular tachycardia or SCD
  • Refusal to consent/inability to provide signed written consent
  • Any condition or abnormality that, at the physician's discretion, would compromise subject safety or data integrity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980574

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Contact: Sarah Brougher, BA 6142923962
Contact: Julie Ryan, BA 6146854619

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United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Julie Ryan, BA    614-685-4619   
Contact: Sarah Brougher    6142923962   
Principal Investigator: William Abraham, MD         
Sub-Investigator: Sitaramesh Emani, MD         
Sub-Investigator: Ayesha Hasan, MD         
Sub-Investigator: Brent Lampert, DO         
Sub-Investigator: Garrie Haas, MD         
Sub-Investigator: Veronica Franco, MD         
Sub-Investigator: Rami Kahwash, MD         
Sub-Investigator: Katherine Dodd, DO         
Sub-Investigator: Laurie Bossary, MD         
Sponsors and Collaborators
Ohio State University
Vascular Scientific, LLC
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Principal Investigator: William Abraham, MD Ohio State University

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Responsible Party: 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, Ohio State University Identifier: NCT03980574     History of Changes
Other Study ID Numbers: 2017H0214
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William Abraham, Ohio State University:
Diabetes Mellitus

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases