Vitamin D and Mortality in Heart Failure

Phase 4

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: placebo; Drug: Vitamin D

• Registration Number: NCT01326650
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief Summary

Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Status Verified: 2015-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• > 18 years of age and < 80 years of age
• New York Heart Association Functional Class > = II

Exclusion Criteria

• pregnancy and lactation
• sarcoidosis
• daily vitamin D intake > 20 micrograms
• serum 25-hydroxyvitamin D > 30 ng/ml
• hypercalcemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	daily placebo supplement
Vitamin D	Vitamin D	daily vitamin D supplement

Primary Outcome Measures

Name	Time	Method
Number of participants who died during the intervention	three years	all-cause mortality (any cause of death) will be assessed

Secondary Outcome Measures

Name	Time	Method
Number of event-free survivors	three years	event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia
Changes in biochemical risk markers	three years	inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
Number of participants with elevated safety parameters	every 6 months	Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml.; Serum calcium should not exceed 2.75 mmol/l.

Trial Locations

Locations (1)

Heart Center North Rhine-Westphalia; 🇩🇪 Bad Oeynhausen, Federal State of North Rhine-Westphalia, Germany