Vitamin D supplementation in normal ejection fraction heart: impact on quality of life: FITNESS study

Background: Studies have shown a significant prevalence of vitamin D (Vit. D) deficits in heart failure patients with reduced ejection fraction(HFREF), related to poorer quality of life andreductions in functional performance. With anaging population, heart failure with preserved ejection fraction (HFPEF) will become the most common type of heart failure (HF), with similar results for HFREF predictions. Despite evidence of the beneficial action of vit. D on the cardiovascular system in HFREF patients, there are no clinical s t u d i e s demo n s t r a t i n g c a rd i o v a s c u l a r morphofunctional improvement through vit.D supplementation in HFPEF patients. Objective: To demonstrate improvements in the quality of life and diastolic function for FPEF patients taking vit. D supplements. Methods: Prospective, double-blind, randomized, placebo-controlled study, with 40 patients with HFNEF and vit. D deficiency (25OHD <30ng/mL)for 20 weeks of treatment. Patients will receive supplements of 100,000IU of cholecalciferol (Vit. D3)or placebo at baseline and at 10 weeks under medical supervision. They will be assessed by: functional tests (timed up-and-go test and 6-minute walk test),laboratory examinations, the Minnesota Living with Heart Failure Questionnaire, electrocardiogram, evaluating systolic and diastolic functions and ventricular remodeling at baseline, and at 10 and 20weeks.Conclusion: The FITNESS study will evaluate cardiovascular morphofunctional impacts and effects on the quality of life during 20 weeks of cholecalciferol supplementation in HFPEF patients with vit. D deficits.