Heart Failure CongestiveNCT01227837
Effect of omega3 on Congestive Heart Failure
A study testing omga3 in people with Heart Failure Congestive, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test. Read more about this study
- Who is it for?
- Ages 3 months to 73 years
- Conditions the study is for
- Heart Failure Congestive
- What is being tested?
- omga3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Mar 2010
- Phase
- Interventional
- 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 3 months to 73 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- EF< 40%
- sinus rhythm
- accept randomization
- having tri-chamber pacemaker
Who cannot join
- survival less than 6 months
- class IV heart failure
- using drugs other than study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Omega 3 Supplementation on Brain Natriuretic Peptide (BNP) Serum Levels Functional Capacity and Systolic and Diastolic Function of Heart Failure Patients
In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test.
Read the detailed description
Introduction: Widely used as lipid lowering agents, Omega 3 fatty acids have been demonstrated to possess the potential to reduce the risk of cardiovascular events in patients suffering from chronic heart conditions. In this double -blinded randomized placebo-controlled clinical trial, we aim to investigate the possible beneficial effects of Omega-3 supplements on echocardiographic parameters and brain natriuretic peptide (BNP) plasma levels in patients suffering from congestive heart failure (CHF).
Methods and Materials: 100 patients with class II and III CHF, who had tri-chamber pacemaker and automated defibrillator( CRT-AICD) were initially recruited among which 70 subjects consented to participate. Subjects were randomly assigned and matched to two treatment groups. 42 patients were allocated to a two gram/day dosing of omega-3 capsule while 28 subjects were allocated to the placebo group. Demographic features and BNP plasma levels, 6-minute walk test and echocardiographic parameters of patients were recorded at baseline and at 6 months after implementation of treatment protocols. Data were further gathered and analyzed to evaluate the beneficial effects of omega-3 supplements compared to placebo.
Conclusion: Beneficial effects of Omega-3 supplementation on CHF patients were not as dramatic as initially presumed
- Conditions
- Heart Failure Congestive
- Being tested
- placebo, omga3
- Keywords
- omega 3, CRT_AICD, congestive heart failure, CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
placebo given to patients
omga3Dietary supplement
use of omega 3
| Study group | Role | What they receive |
|---|---|---|
| placebo | Sham comparator | use of placebo in control group Receives: Dietary Supplement: placebo |
| omega 3 | Experimental | use of omega 3 2 gr/day for 6 months Receives: Dietary Supplement: omga3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNP level
level of BNP in serum of patient prior and 6 months post recruitment
Measured: 6 months
six minutes walk test
ability to walk in six minutes after and before to syudy
Measured: 6 months
echocardiographic data
Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study
Measured: 6 months
Secondary outcomes (2)
mortality
any cardiac mortality in 6 months
Measured: 6 months
hospital admission
any hospital admission due to cardiac problem in 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure CongestiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227837
- Sponsor's protocol ID
- 1388-2365
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kojuri J, Ostovan MA, Rezaian GR, Archin Dialameh P, Zamiri N, Sharifkazemi MB, Jannati M. Effect of omega-3 on brain natriuretic peptide and echocardiographic findings in heart failure: Double-blind placebo-controlled randomized trial. J Cardiovasc Dis Res. 2013 Mar;4(1):20-4. doi: 10.1016/j.jcdr.2013.02.013. Epub 2013 Feb 27.
PubMed 24023466
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Supplementation on Brain Natriuretic Peptide (BNP) Serum Levels Functional Capacity and Systolic and Diastolic Function of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01227837
- Acronym / sponsor ID
- 1388-2365
- Conditions
- Heart Failure Congestive
- Keywords
- omega 3, CRT_AICD, congestive heart failure, CHF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010
- First posted
- 25 Oct 2010 (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.
In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test.
Detailed description
Introduction: Widely used as lipid lowering agents, Omega 3 fatty acids have been demonstrated to possess the potential to reduce the risk of cardiovascular events in patients suffering from chronic heart conditions. In this double -blinded randomized placebo-controlled clinical trial, we aim to investigate the possible beneficial effects of Omega-3 supplements on echocardiographic parameters and brain natriuretic peptide (BNP) plasma levels in patients suffering from congestive heart failure (CHF).
Methods and Materials: 100 patients with class II and III CHF, who had tri-chamber pacemaker and automated defibrillator( CRT-AICD) were initially recruited among which 70 subjects consented to participate. Subjects were randomly assigned and matched to two treatment groups. 42 patients were allocated to a two gram/day dosing of omega-3 capsule while 28 subjects were allocated to the placebo group. Demographic features and BNP plasma levels, 6-minute walk test and echocardiographic parameters of patients were recorded at baseline and at 6 months after implementation of treatment protocols. Data were further gathered and analyzed to evaluate the beneficial effects of omega-3 supplements compared to placebo.
Conclusion: Beneficial effects of Omega-3 supplementation on CHF patients were not as dramatic as initially presumed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Sham comparator | Dietary Supplement: placebouse of placebo in control group |
| omega 3 | Experimental | Dietary Supplement: omga3use of omega 3 2 gr/day for 6 months |
Who may qualify
- Ages
- 3 months to 73 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- EF< 40%
- sinus rhythm
- accept randomization
Key exclusion criteria (3 listed)
- survival less than 6 months
- class IV heart failure
- using drugs other than study protocol
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 |
|---|---|---|
| placeboplacebo given to patients | Dietary supplement | placebo |
| omga3use of omega 3 | Dietary supplement | omega 3 |
Primary outcome
BNP level
Time frame: 6 months
level of BNP in serum of patient prior and 6 months post recruitment
six minutes walk test
Time frame: 6 months
ability to walk in six minutes after and before to syudy
echocardiographic data
Time frame: 6 months
Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study
2 secondary outcomes
mortality
Time frame: 6 months
hospital admission
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
- Derived from this study: PubMed 24023466Kojuri J, Ostovan MA, Rezaian GR, Archin Dialameh P, Zamiri N, Sharifkazemi MB, Jannati M. Effect of omega-3 on brain natriuretic peptide and echocardiographic findings in heart failure: Double-blind placebo-controlled randomized trial. J Cardiovasc Dis Res. 2013 Mar;4(1):20-4. doi: 10.1016/j.jcdr.2013.02.013. Epub 2013 Feb 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omga3 in people with Heart Failure Congestive, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 3 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: finished, as of the sponsor's last update on 25 Oct 2010. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNP level (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227837, which also lists 1 linked publication.
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 25 Oct 2010.