Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia
Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 29, 2011
November 1, 2011
1.6 years
June 22, 2011
November 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function
Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.
3 months
Study Arms (2)
Omega-3 fatty acid
EXPERIMENTALCiprofibrate
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Pedro Ernesto
Rio de Janeiro, RJ, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 22, 2011
First Posted
November 29, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 29, 2011
Record last verified: 2011-11