ArrhythmiaPhase 2/3NCT00749307
Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
A Phase 2/3 study testing Docosahexaenoic acid (DHA) in people with Arrhythmia, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Docosahexaenoic acid (DHA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age above 65 years
Who cannot join
- Treatment with or allergy to polyunsaturated fatty acids
- Diagnosis of arrhythmia or antiarrhythmic therapy
- Anticoagulant therapy (except acetylsalicylic acid)
- Pacemaker
- Bleeding diathesis
- Recent cerebral hemorrhage (less than 6 months)
- Thyroid dysfunction
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Rome, RM, 00163
About this study
Official title: Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients
The purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients.
Read the detailed description
In western countries, sudden cardiac death (SCD) represents the most common form of cardiovascular death. SCD is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons.
In the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) against SCD both in healthy persons and in patients affected by coronary artery disease.
The hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 LCPUFA, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control.
This pathway, in particular, has been confirmed by the analysis of changes in heart rate variability.
Most studies in this field used n-3 LCPUFA derived from fish oil, composed by a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At our knowledge there are few studies available evaluating the isolated role of DHA, derived from alternative sources of n-3 LCPUFA, as the microalgae, in the prevention of fatal arrhythmias.
- Conditions
- Arrhythmia
- Being tested
- Docosahexaenoic acid (DHA), Placebo
- Keywords
- Heart rate variability, Docosahexaenoic acid, DHA, Long chain fatty acids, Long chain polyunsaturated fatty acids, Algal fatty acids, Schizochytrium, Omega 3, Death, Sudden, Cardiac, Arrhythmias, Cardiac
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid (DHA)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Docosahexaenoic acid (DHA) |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Measured: basal - 12 weeks - 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, dsm-firmenich Switzerland AG, Pharmanutra s.r.l.
- Investigators
- Raffaele Antonelli Incalzi, MD, Study director, Campus Bio-Medico UniversityGiuseppe Rosano, MD, Study director, IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.Francesco M Serino, MD, Principal investigator, Campus Bio-Medico UniversityMarco Miceli, MD, Principal investigator, IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749307
- Sponsor's protocol ID
- ALFAHRV01
- Other IDs
- EudraCT number 2008-005715-18
- Status last verified
- Nov 2009
- First submitted
- 8 Sep 2008
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients
- ClinicalTrials.gov ID
- NCT00749307
- Acronym / sponsor ID
- ALFAHRV01
- Conditions
- Arrhythmia
- Keywords
- Heart rate variability, Docosahexaenoic acid, DHA, Long chain fatty acids, Long chain polyunsaturated fatty acids, Algal fatty acids, Schizochytrium, Omega 3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, dsm-firmenich Switzerland AG, Pharmanutra s.r.l.
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Sep 2008 (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 purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients.
Detailed description
In western countries, sudden cardiac death (SCD) represents the most common form of cardiovascular death. SCD is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons.
In the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) against SCD both in healthy persons and in patients affected by coronary artery disease.
The hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 LCPUFA, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control.
This pathway, in particular, has been confirmed by the analysis of changes in heart rate variability.
Most studies in this field used n-3 LCPUFA derived from fish oil, composed by a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At our knowledge there are few studies available evaluating the isolated role of DHA, derived from alternative sources of n-3 LCPUFA, as the microalgae, in the prevention of fatal arrhythmias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA) |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age above 65 years
Key exclusion criteria (7 listed)
- Treatment with or allergy to polyunsaturated fatty acids
- Diagnosis of arrhythmia or antiarrhythmic therapy
- Anticoagulant therapy (except acetylsalicylic acid)
- Pacemaker
- Bleeding diathesis
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 |
|---|---|---|
| Docosahexaenoic acid (DHA) | Dietary supplement | 1 |
| Placebo | Dietary supplement | 2 |
Primary outcome
Heart rate variability (HRV)
Time frame: basal - 12 weeks - 30 weeks
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 Nov 2009.
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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.
Raffaele Antonelli Incalzi, MD study director
Campus Bio-Medico University
Giuseppe Rosano, MD study director
IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Francesco M Serino, MD principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docosahexaenoic acid (DHA) in people with Arrhythmia, run by Campus Bio-Medico University at 1 site in Italy.
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 1 inclusion and 7 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 Nov 2009. 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 Italy. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Heart rate variability (HRV) (time frame: basal - 12 weeks - 30 weeks). 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 25 Nov 2009.