Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
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|ClinicalTrials.gov Identifier: NCT00749307|
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : November 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmia||Dietary Supplement: Docosahexaenoic acid (DHA) Dietary Supplement: Placebo||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||November 2009|
|Experimental: 1||Dietary Supplement: Docosahexaenoic acid (DHA)|
|Placebo Comparator: 2||Dietary Supplement: Placebo|
- Heart rate variability (HRV) [ Time Frame: basal - 12 weeks - 30 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749307
|IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.|
|Rome, RM, Italy, 00163|
|Study Director:||Raffaele Antonelli Incalzi, MD||Campus Bio-Medico University|
|Study Director:||Giuseppe Rosano, MD||IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.|
|Principal Investigator:||Francesco M Serino, MD||Campus Bio-Medico University|
|Principal Investigator:||Marco Miceli, MD||IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.|