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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
Sponsor:
Collaborators:
IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.
Information provided by:
Campus Bio-Medico University

Brief 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.

Condition or disease Intervention/treatment Phase
Arrhythmia Dietary Supplement: Docosahexaenoic acid (DHA) Dietary Supplement: Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Doconexent
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Dietary Supplement: Docosahexaenoic acid (DHA)
Placebo Comparator: 2 Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Heart rate variability (HRV) [ Time Frame: basal - 12 weeks - 30 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 65 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Italy
IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Rome, RM, Italy, 00163
Sponsors and Collaborators
Campus Bio-Medico University
IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.
Investigators
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.

Responsible Party: Francesco Maria Serino, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT00749307     History of Changes
Other Study ID Numbers: ALFAHRV01
EudraCT number 2008-005715-18
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Campus Bio-Medico University:
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