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

Vitamin D Deficiency Clinical Trial

— D-Heart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03289637
• Other study ID #: D-88538-Sw
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2017
• Last updated: March 6, 2018
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2018
• Source: Linkoeping University
• Contact: Urban Alehagen, Prof
• Phone: +46-10-1030000
• Email: urban.alehagen[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Sweden	Dept of Cardiology, University Hospital of Linköping	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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