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Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Primary Purpose

Hypertension, Hypertriglyceridemia

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

DHA-EPA

Ciprofibrate

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Endothelial dysfunction, Vascular stiffness

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Universitario Pedro ErnestoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omega-3 fatty acid

Ciprofibrate

Arm Description

Outcomes

Primary Outcome Measures

Endothelial function

Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.

Secondary Outcome Measures

Full Information

NCT ID

NCT01480687

First Posted

June 22, 2011

Last Updated

November 23, 2011

Sponsor

Hospital Universitario Pedro Ernesto

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

1. Study Identification

Unique Protocol Identification Number

NCT01480687

Brief Title

Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Official Title

Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario Pedro Ernesto

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hypertriglyceridemia

Keywords

Hypertension, Endothelial dysfunction, Vascular stiffness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 fatty acid

Arm Type

Experimental

Arm Title

Ciprofibrate

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

DHA-EPA

Other Intervention Name(s)

OMEVITS

Intervention Description

1800 mg/day

Intervention Type

Drug

Intervention Name(s)

Ciprofibrate

Other Intervention Name(s)

LIPLESS

Intervention Description

100 mg/day

Primary Outcome Measure Information:

Title

Endothelial function

Description

Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcela A. Casanova, MSc

Phone

55-21-2868-8484

cela.abreu@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mario F. Neves, MD, PhD

Phone

55-21-2868-8485

mariofneves@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcela A Casanova, MSc

Organizational Affiliation

State University of Rio de Janeiro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mario F Neves, MD, PhD

Organizational Affiliation

State University of Rio de Janeiro

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wille Oigman, MD, PhD

Organizational Affiliation

State University of Rio de Janeiro

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Fernanda J Medeiros, PhD

Organizational Affiliation

Federal University of the State of Rio de Janeiro

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Universitario Pedro Ernesto

City

Rio de Janeiro, RJ

State/Province

Rio de Janeiro

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcela A Casanova, MSc

Phone

55-21-2868-8484

cela.abreu@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

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