EFFECT OF VITAMIN D ON THE VENTRICULAR FUNCTION IN PATIENTS WITH HEART FAILURE

Phase 1

• Conditions: Heart failure with preserved or moderately reduced eyection fraction; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001488-21-ES
• Lead Sponsor: Sergio Aleman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

A.- Heart failure with preserved or moderately reduced ejection fraction (HFp / HFmr) that meet diagnostic criteria according to the Clinical Guidelines of the European Society of Cardiology :
- At least one episode of symptoms and / or signs of heart failure in the last 6 months.
- Demonstrated ejection fraction> 40% (including clinical entities of preserved and moderately reduced ejection fraction).
- Elevation natriuretic peptides: NTproBNP> 125 pg / ml or
BNP> 35 pg / ml
- Demonstration of structural heart disease: Left ventricular hypertrophy / left atrial enlargement / diastolic dysfunction
B.- Vitamin D deficiency demonstrated with serum levels <20 ng / mL (vitamin deficit).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

- Active treatment with Vitamin D supplements.
- Advanced chronic kidney disease with glomerular filtration <30 ml / min / 1.73m2.
- Malabsorptive syndromes that interfere with the absorption of vitamin D.
- Diseases that affect the metabolism of calcium and phosphorus.
- Hypercalcemia (serum calcium corrected with albumin> 10.5 mg / dL).
- Severe valvular disease of any origin.
- Atrial fibrillation.
- Severe psychosocial problems (dementia, alcoholism, any consumption of toxics, psychiatric disorders or moderate or severe cognitive impairment of any origin that prevent the patient's follow-up or adherence to the study).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified