Dietary Supplementation in Heart Failure (R-DRINK)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Crossover Group
Non-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).
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.