Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).

Study Overview
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Brief Summary
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In 200 patients with documented systolic heart failure give supplementation with vitamin D in those with a 25-OH- vitamin D < 50nmol/L - or placebo. In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given. Intervention time 12 months. Biomarkers of heart function, quality of life, and hospitalisation will be analysed.

Detailed Description
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In a population with a systolic heart failure with an EF<40%, the levels of vitamin D will be analysed. In those with a 25-OH-vitamin D level <50nmol/L the patients that accept participation, will be randomised into active supplementation as described below, or placebo. In those with a 25-OH-vitamin D level <25nmol/L there will be a supplementation of 2400IU daily In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU daily, or placebo. Thus based on the basal level of vitamin D the screened patients will either be excluded due to high level of vitamin D, or given one ot the two options of vitamin D dosage based on the basal patient level - or placebo. The intervention time will be 12 months. In the project 200 heart failure patients will be included. Blood samples including heart failure biomarkers, and biomarkers for inflammation and oxidative stress will be drawn at 3,6, 9 and 12 months. Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaire, as also hospitalisation during the project time. Cardiac function according to echocardiography will be analysed at start, and study end.

Official Title
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Supplementation With Vitamin D to Patients With Heart Failure. Effects on Symptoms, Quality-of-life and Disease Processes.

Conditions
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Heart Failure With Reduced Ejection Fraction, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented and stable systolic heart failure and connected to an outpatient clinic at the Dept of Cardiology in Linköping, or Jönköping, Sweden, and with a 25-OH-vitamin D <50nmol/L Exclusion Criteria: Patients with unstable heart failure Patients with significant valvular disease, or ischemic heart disease planned for operation Patients with significant renal or /and liver impairment. Patients that do not understand that study information, or that are not willing to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, parallel, placebo controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active intervention<br>In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given. In those randomised to active treatment and with a screening level of 25-OH-vitamin D of <25nmol/L, an intervention of 2400IE of vitamin D will be given. | Dietary Supplement: Vitamin D<br>* Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening<br>|
| Placebo Comparator: Placebo<br>In the group randomised to placebo and with a screening level of 25-OH-vitamin D <50 mol/L, the participants will be given placebo. | Dietary Supplement: Vitamin D<br>* Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the composite endpoint for heart failure | Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint | Follow-up 12 months after stop of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence on quality of life in patients with heart failure by the intervention | Effect on health related quality of life as measured by the Euro-QoL-5D Minnesota Living with Heart Failure. Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaires | Follow-up 12 months after stop of intervention |