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Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

H

Hospital Universitario Pedro Ernesto

Status and phase

Unknown
Phase 4

Conditions

Hypertension
Hypertriglyceridemia

Treatments

Dietary Supplement: DHA-EPA
Drug: Ciprofibrate

Study type

Interventional

Funder types

Other

Identifiers

NCT01480687
FO-1800

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

52 participants in 2 patient groups

Omega-3 fatty acid
Experimental group
Treatment:
Dietary Supplement: DHA-EPA
Ciprofibrate
Active Comparator group
Treatment:
Drug: Ciprofibrate

Trial contacts and locations

1

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Central trial contact

Marcela A. Casanova, MSc; Mario F. Neves, MD, PhD

Data sourced from clinicaltrials.gov

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