Overview

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

Status:
Unknown status
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Unita' Sanitaria Locale Di Modena
Collaborator:
Abiogen Pharma
Treatments:
Cholecalciferol
Vitamin D
Criteria
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...)