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

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

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Dietary supplement: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58191
    • Recruiting
    • Dept of Cardiology, University Hospital of Linköping
    • Contact: Peter Wodlin, MD; Email: peter.wodlin@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active intervention; 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; Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening
Placebo Comparator: Placebo; 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; Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening

What is the study measuring?

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

Other 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 Minnesota Living with Heart Failure	Follow-up 12 months after termination of the intervention
Influence on symptoms of depression in patients with heart failure by the intervention	Patient Health Questionnaire-9 (PHQ-9)	Follow-up 12 months after termination of intervention
Influence on perceived fatigue in patients with heart failure by the intervention	Effect on as measured using the Multidimensional Fatigue Inventory 20	Follow-up 12 months after termination of the intervention

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Urban Alehagen, Prof, University of Linkoping

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Heart Failure; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: D-88538-Sw

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No