Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Phase 4

• Conditions: Hypertension; Hypertriglyceridemia
• Interventions: Dietary Supplement: DHA-EPA; Drug: Ciprofibrate

• Registration Number: NCT01480687
• Lead Sponsor: Hospital Universitario Pedro Ernesto

Brief Summary

The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Detailed Description

Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-22
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Previous diagnosis of hypertension
• Patients with serum triglycerides levels ≥ 150 mg/dl and <500 mg/dl
• Patients on stable antihypertensive medication for at least 4 weeks
• Patients with food consumption maintained for at least 4 weeks

Exclusion Criteria

• Smoking
• Secondary hypertension
• Hormone replacement therapy
• Diabetes mellitus
• Chronic kidney disease
• Known coronary artery disease
• Previous stroke
• Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl
• Use of statins or beta blockers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acid	DHA-EPA	-
Ciprofibrate	Ciprofibrate	-

Primary Outcome Measures

Name	Time	Method
Endothelial function	3 months	Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.

Trial Locations

Locations (1)

Hospital Universitario Pedro Ernesto; 🇧🇷 Rio de Janeiro, RJ, Rio de Janeiro, Brazil