HypertensionPhase 4NCT01480687
Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia
A Phase 4 study testing DHA-EPA and Ciprofibrate in people with Hypertension and Hypertriglyceridemia, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension, Hypertriglyceridemia
- What is being tested?
- DHA-EPA and Ciprofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoking
- Secondary hypertension
- Hormone replacement therapy
- Diabetes mellitus
- Chronic kidney disease
- Known coronary artery disease
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- Previous stroke
- Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl
- Use of statins or beta blockers
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitario Pedro Ernesto
Rio de Janeiro, RJ, Rio de Janeiro
Marcela A Casanova, MSc, 55-21-2868-8484, cela.abreu@gmail.com
About this study
Official title: Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
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.
Read the 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.
- Conditions
- Hypertension, Hypertriglyceridemia
- Being tested
- DHA-EPA, Ciprofibrate
- Keywords
- Hypertension, Endothelial dysfunction, Vascular stiffness
- Medical subject headings
- Hypertension, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-EPADietary supplement
Also called OMEVITS
1800 mg/day
CiprofibrateDrug
Also called LIPLESS
100 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid | Experimental | Not described Receives: Dietary Supplement: DHA-EPA |
| Ciprofibrate | Active comparator | Not described Receives: Drug: Ciprofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
- Investigators
- Marcela A Casanova, MSc, Principal investigator, State University of Rio de JaneiroMario F Neves, MD, PhD, Study chair, State University of Rio de JaneiroWille Oigman, MD, PhD, Study chair, State University of Rio de JaneiroFernanda J Medeiros, PhD, Study chair, Federal University of the State of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480687
- Sponsor's protocol ID
- FO-1800
- Status last verified
- Nov 2011
- First submitted
- 22 Jun 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01480687
- Acronym / sponsor ID
- FO-1800
- Conditions
- Hypertension, Hypertriglyceridemia
- Keywords
- Hypertension, Endothelial dysfunction, Vascular stiffness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid | Experimental | Dietary Supplement: DHA-EPA |
| Ciprofibrate | Active comparator | Drug: Ciprofibrate |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Smoking
- Secondary hypertension
- Hormone replacement therapy
- Diabetes mellitus
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA-EPAAlso: OMEVITS1800 mg/day | Dietary supplement | Omega-3 fatty acid |
| CiprofibrateAlso: LIPLESS100 mg/day | Drug | Ciprofibrate |
Primary outcome
Endothelial function
Time frame: 3 months
Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela A Casanova, MSc principal investigator
State University of Rio de Janeiro
Mario F Neves, MD, PhD study chair
State University of Rio de Janeiro
Wille Oigman, MD, PhD study chair
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DHA-EPA and Ciprofibrate in people with Hypertension and Hypertriglyceridemia, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcela A. Casanova, MSc (55-21-2868-8484, cela.abreu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.