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Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Mario Fritsch Neves, Hospital Universitario Pedro Ernesto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480687
First Posted: November 29, 2011
Last Update Posted: November 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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:


Further study details as provided by Mario Fritsch Neves, Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 3 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mario Fritsch Neves, MD, PhD, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01480687     History of Changes
Other Study ID Numbers: FO-1800
First Submitted: June 22, 2011
First Posted: November 29, 2011
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Mario Fritsch Neves, 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
Lipid Regulating Agents