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Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

This study is currently recruiting participants.
Verified November 2011 by Hospital Universitario Pedro Ernesto
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01480687
First received: June 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Hypertriglyceridemia
 Dietary Supplement: DHA-EPA
Drug: Ciprofibrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.


Estimated Enrollment: 52
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 fatty acid Dietary Supplement: DHA-EPA
1800 mg/day
Other Name: OMEVITS
Active Comparator: Ciprofibrate Drug: Ciprofibrate
100 mg/day
Other Name: LIPLESS

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480687

Contacts
Contact: Marcela A. Casanova, MSc 55-21-2868-8484 cela.abreu@gmail.com
Contact: Mario F. Neves, MD, PhD 55-21-2868-8485 mariofneves@gmail.com

Locations
Brazil
Hospital Universitario Pedro Ernesto Recruiting
Rio de Janeiro, RJ, Rio de Janeiro, Brazil
Contact: Marcela A Casanova, MSc     55-21-2868-8484     cela.abreu@gmail.com    
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Marcela A Casanova, MSc State University of Rio de Janeiro
Study Chair: Mario F Neves, MD, PhD State University of Rio de Janeiro
Study Chair: Wille Oigman, MD, PhD State University of Rio de Janeiro
Study Chair: Fernanda J Medeiros, PhD Federal University of the State of Rio de Janeiro
  More Information

No publications provided

Responsible Party: Mario Fritsch Neves, MD, PhD, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01480687     History of Changes
Other Study ID Numbers: FO-1800
Study First Received: June 22, 2011
Last Updated: November 23, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitario Pedro Ernesto:
Hypertension
Endothelial dysfunction
Vascular stiffness

Additional relevant MeSH terms:
Hypertension
Hypertriglyceridemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Ciprofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013