Vitamine D Treatment in Chronic Heart Failure

• Status: Terminated
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure.

Type of study: Controlled, randomized, double blind, placebo control

Number of patient: 300; 150 treated and 150 placebo controlled

Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month

Duration of study:1+1 year

Primary end points:

Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,

Secondary end points:

Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes

Visits:

Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Semmelweis University
• Treatments: Cholecalciferol; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• NYHA II-IV

• vitamin D level between 10-30 ng/ml

• ejection fraction by ultrasound < 40 %

Exclusion Criteria:

• blood calcium > 2,6 mmol/l

• urinary calcium > 0,1 mmol/body weight kg/die

• blood phosphorus > 1,45 mmol/l

• nephrolithiasis in the history

• GFR < 30 ml/min

• vitamin D injection in the last 6 month

• actual 1,25-OH2-D3 vitamin treatment

• Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation

• serious valve disease