| Outcome Measures: |
Primary: Longitudinal change in the scores, Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health questionnaire. Scoring: The questionnaire has two scores: Physical Health (physical health, physical function, pain, and fatigue items) and Mental Health (quality of life, mental health, satisfaction with discretionary social activities, and emotional problem items). In all cases, a high score means more of domain. T scores for both Physical and Mental Health scales. In all cases, a high score means more of domain. For example, higher scores on physical functioning measure indicate better health., Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)|Longitudinal change in the scores, Modified Kansas City Cardiomyopathy questionnaire (KCCQ) - All KCCQ scores are scaled from 0 to 100. A higher score indicates better health status., Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)|Longitudinal change in the scores, Patient-Reported Outcomes Measurement Information System (PROMIS®) Scale v1.0 - Gastrointestinal Belly Pain 5a questionnaire. The PROMIS GI measures use a T-score centered on the U.S. General Population. This means that a score of 50 represents the average of the general population (and that 10 represents the standard deviation). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like belly pain, a T-score of 60 is one SD worse than average. By comparison, a gastrointestinal symptom T-score of 40 is one SD better than average., Seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)|Longitudinal change in both systolic and diastolic blood pressure, Unit of measurement - millimeters of mercury (mmHg), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in 8-isoprostane in plasma, Unit of measurement - picograms per milliliter (pg/mL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in 8-isoprostane in urine, Unit of measurement - picograms per milliliter (pg/mL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in urinary albumin, Unit of measurement - μg/ml, Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in protein/creatinine ratio, Unit of measurement - milligram per gram (mg/g), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in plasma hydrogen sulfide, Unit of measurement - Nanomolar (nM), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in plasma interleukin-6, Unit of measurement - picograms per milliliter (pg/mL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in urine nephrin, Unit of measurement - microgram per milliliter μg/mL, Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in messenger RNA (mRNA) levels of cytoprotective enzymes in peripheral blood mononuclear cells (PBMCs), Unit of measurement - Relative copy number, Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in messenger RNA (mRNA) levels of heat shock proteins in peripheral blood mononuclear cells (PBMCs), Unit of measurement - Relative copy number, Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in sodium as part of comprehensive metabolic panel (CMP), Unit of measurement - Millimoles per liter (mmol/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in potassium as part of comprehensive metabolic panel (CMP), Unit of measurement - Millimoles per liter (mmol/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in chloride as part of comprehensive metabolic panel (CMP), Unit of measurement - Millimoles per liter (mmol/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in carbon Dioxide as part of comprehensive metabolic panel (CMP), Unit of measurement - Millimoles per liter (mmol/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in anion Gap as part of comprehensive metabolic panel (CMP), Unit of measurement - milliequivalents per liter (mEq/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in blood urea nitrogen as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in creatinine as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in estimated Glomerular Filtration Rate (eGFR) as part of comprehensive metabolic panel (CMP), Unit of measurement - milliliters of cleansed blood per minute per body surface (mL/min/1.73m2), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in calcium as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in total protein as part of comprehensive metabolic panel (CMP), Unit of measurement - Grams Per Deciliter (g/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in albumin as part of comprehensive metabolic panel (CMP), Unit of measurement - Grams Per Deciliter (g/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in total bilirubin as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in aspartate transaminase (AST) as part of comprehensive metabolic panel (CMP), Unit of measurement - units per liter (U/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in alanine transaminase (ALT) as part of comprehensive metabolic panel (CMP), Unit of measurement - units per liter (U/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in alkaline phosphatase (ALP) as part of comprehensive metabolic panel (CMP), Unit of measurement - units per liter (U/L), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in phosphorus as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6)|Longitudinal change in glucose as part of comprehensive metabolic panel (CMP), Unit of measurement - Milligrams per decilitre (mg/dL), Four timepoints per patient (baseline, month 1, month 3, and month 6) |
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