Heart Failure With Reduced Ejection Fraction, Vitamin D Deficiency
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level\<50nmol/L at screening
Sponsors
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Neither the participant, nor the care provider will be informed if active supplementation or placebo will be given, nor will blood sample results be open for care provider
Intervention model description
Double blind, parallel, placebo controlled study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in the composite endpoint for heart failure | Follow-up 12 months after stop of intervention | Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence on quality of life in patients with heart failure by the intervention | Follow-up 12 months after stop of 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence on quality of life in patients with heart failure by the intervention | Follow-up 12 months after termination of the intervention | Effect on health related quality of life as measured by Minnesota Living with Heart Failure |
| Influence on symptoms of depression in patients with heart failure by the intervention | Follow-up 12 months after termination of intervention | Patient Health Questionnaire-9 (PHQ-9) |
| Influence on perceived fatigue in patients with heart failure by the intervention | Follow-up 12 months after termination of the intervention | Effect on as measured using the Multidimensional Fatigue Inventory 20 |
Countries
Sweden
Contacts
Primary ContactUrban Alehagen, Prof
Backup ContactPeter Johansson, Ass Prof
Outcome results
None listed