Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure

Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction
and an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure
will be recruited. This is a one group study with Veterans serving as their own control.
They will receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months.
Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks
then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will
be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of
thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months
and one year. Quality of life will be measured using the Minnesota Living with Heart Failure
questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition
focused physical examination and three days food records will also be measured at baseline,
month 3, 6 and one year.

Inclusion Criteria:

- stable CHF (three months without an exacerbation or major change in medication
regimen and cardiology provider determined medication regimen (angiotensin II
receptor blockers (ARBs), aldosterone, angiotensin converting enzyme (ACE) inhibitors
and Beta blockers) has been maximized), Stage B, C or D CHF resulting from ischemic
cardiomyopathy with an ejection fraction ≤ 45% with or without a pacemaker or
defibrillator . Potential participants who require further medication titration to
attain maximal benefit, will need to wait 30 days after the provider has maximized
the dose of medication to participate.

Exclusion Criteria:

- recent (within the last three months) acute myocardial infarction, or unstable
angina, pacemaker or defibrillator placed less than six months prior, or anticipated
pacemaker or defibrillator placement in the next six months, or a bi ventricular
pacemaker, corticosteroid use (> 20 mg Prednisone use or its equivalent per day > 2
weeks duration), isoniazid therapy, use of the study nutrition supplements at the
study doses for the past month or longer,(if the participant has been taking a
multivitamin or multivitamin with minerals , or other water soluble vitamins they
will need to stop taking these for at least one month prior to initiating the study
intervention), end-stage liver disease, end-stage renal disease requiring dialysis,
receiving chemotherapy or radiation therapy, active alcohol/ substance abuse,
pregnancy /lactation, women of childbearing potential who do not have medical
documentation of surgically induced menopause, pancreatitis, any psychological issues
like severe depression, claustrophobia, active problematic post-traumatic stress
disorder (PTSD), or memory loss that prevents compliance with the supplement intake,
agoraphobia which may interfere attendance at research visits or fear of needles
which would limit their ability to have the blood tests completed, and any active
eating disorders. Cardiac Magnetic Resonance Imaging (MRI) scan will not be used to
test cardiac function in participants with a pacemaker or defibrillator. Nor will it
be used for potential subjects with ferro magnetic materials (i.e., penile
stimulator), inability to lie flat for up to one hour, inability to hold their breath
for up to 15 seconds or those with claustrophobia.