Dietary Supplementation in Heart Failure

NCT03980574 | Completed

• 1 other identifier: 2017H0214
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission Rates

  Number of total hospital readmissions post-enrollment.

  Day 119

Other Outcomes (9)

• New York Heart Association Functional Class

  Day 0, Day 119

• Echocardiographic Measurements

  Day 0, Day 56, Day 119

• Quality of Life Questionnaires

  Day 0, Day 56, Day 119

Study Arms (2)

Crossover Group

EXPERIMENTAL

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

Non-crossover Group

EXPERIMENTAL

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

Interventions

R Drink DIETARY_SUPPLEMENT

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.

Crossover Group; Non-crossover Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Vascular Scientific, LLC: collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sitaramesh Emani, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 2 arms of studying with first arm involving a cross-over from active intervention to no intervention and a second arm involving active intervention with no cross-over.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: June 10, 2019
• Study Start: April 1, 2019
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)