Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
|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|
|Primary Completion Date :||September 2009|
|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 ]
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.|