Chronic heart failure Circulatory System Other rheumatic heart diseases
Conditions
Interventions
100 µg vitamin D or placebo per day for 12 months
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Class II and III heart failure due to left ventricular systolic dysfunction (left ventricular ejection fraction less than or equal to 40%) 2. Stable symptoms for 3 months on maximally tolerated medical therapy with no recent change in medication 3. Able to give informed written consent 4. Aged greater than 18 years, both sexes
Exclusion criteria
Exclusion criteria: 1. Currently taking (or have taken in the previous 3 months) calcium or other vitamin supplements 2. Currently prescribed amlodipine or other calcium channel antagonists (intake of spironolactone will be recorded) 3. CHF due to untreated valvular heart disease 4. History of primary hyperparathyroidism, sarcoidosis, tuberculosis or lymphoma 5. Vitamin D levels greater than 50 nmol/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular function, assessed by cardiac magnetic resonance at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom status (New York Heart Association status), measured at baseline, 1, 4, 8 and 12 months 2. Exercise tolerance, measured at baseline and 12 months 3. Quality of life (Minnesota living with heart failure questionnaire, European Quality of Life instrument [EQ5D] and a 19-item Likert scale index [CASP-19]), measured at baseline, 1, 4, 8 and 12 months 4. Flow-mediated dilatation, measured at baseline and 12 months 5. Immune status, measured at baseline and 12 months 6. Insulin resistance, measured at baseline and 12 months 7. Autonomic activation, measured by heart rate variability at baseline and 12 months 8. Renal function, measured at baseline, 1, 4, 8 and 12 months 9. B-type natriuretic peptide (BNP), measured at baseline, 1, 4, 8 and 12 months | — |
Countries
United Kingdom
Outcome results
None listed