Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels

Azienda Unita' Sanitaria Locale Di Modena34 enrolled

Overview

The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves: 1. performance at six minutes walking test 2. echocardiographic parameters 3. neurohormonal imbalance

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure Vitamin D Deficiency

Interventions

CHOLECALCIFEROLDRUG

Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months

PLACEBODRUG

Standard guideline based therapy plus placebo

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heart failure diagnosis according to European Society of Cardiology Guideline criteria * Age \> 60 years old * 25(OH) Vitamin D level \< 30 ng/ml * Clinical and therapeutic stability for one month (NYHA class II or III) Exclusion Criteria: * Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine * Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation * Nephrolitiasis, Sarcoidosis or hypercalcemia * Recent (three months) acute coronary syndrome or stroke or major vascular surgery * Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)

Locations (1)

Medicina Cardiovascolare - NOCSAE - Azienda USL

Modena, (mo), Italy

RECRUITING

Outcomes

Primary Outcomes

SIX MINUTE WALKING TEST DISTANCE

Time frame: six months

Secondary Outcomes

ECHOCARDIOGRAPHIC PARAMETERS

Time frame: six months

NEUROHORMONAL CHANGES

Time frame: six months

Central Contacts

Fabrizio Turrini, MD

CONTACT

0039593961100 f.turrini@ausl.mo.it

Data from ClinicalTrials.gov

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