Clinical trial NCT03289637: Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).
Official title: Supplementation With Vitamin D to Patients With Heart Failure. Effects on Symptoms, Quality-of-life and Disease Processes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Vitamin D Deficiency
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-09-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, parallel, placebo controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in the composite endpoint for heart failure
timeFrame: Follow-up 12 months after stop of intervention
Secondary outcomes:
measure: Influence on quality of life in patients with heart failure by the intervention
timeFrame: Follow-up 12 months after stop of intervention
Other outcomes:
measure: Influence on quality of life in patients with heart failure by the intervention
timeFrame: Follow-up 12 months after termination of the intervention
measure: Influence on symptoms of depression in patients with heart failure by the intervention
timeFrame: Follow-up 12 months after termination of intervention
measure: Influence on perceived fatigue in patients with heart failure by the intervention
timeFrame: Follow-up 12 months after termination of the intervention
Locations:
city: Linköping
country: Sweden
facility: Dept of Cardiology, University Hospital of Linköping
Study officials:
affiliation: University of Linköping
name: Urban Alehagen, Prof
role: PRINCIPAL_INVESTIGATOR
References: