Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients

This study has been completed.
Sponsor:
Collaborators:
IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.
Information provided by:
Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT00749307
First received: September 8, 2008
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Arrhythmia
Dietary Supplement: Docosahexaenoic acid (DHA)
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Heart rate variability (HRV) [ Time Frame: basal - 12 weeks - 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Docosahexaenoic acid (DHA)
Placebo Comparator: 2 Dietary Supplement: Placebo

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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
Study First Received: September 8, 2008
Last Updated: November 24, 2009
Health Authority: Italy: National Institute of Health

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014