Clinical trial NCT00749307: Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
Official title: Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arrhythmia
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
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: DSM Nutritional Products, Inc.
name: Pharmanutra s.r.l.
First posted: 2008-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: basal - 12 weeks - 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
state: RM
Study officials:
affiliation: Campus Bio-Medico University
name: Raffaele Antonelli Incalzi, MD
role: STUDY_DIRECTOR
affiliation: IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
name: Giuseppe Rosano, MD
role: STUDY_DIRECTOR
affiliation: Campus Bio-Medico University
name: Francesco M Serino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.
name: Marco Miceli, MD
role: PRINCIPAL_INVESTIGATOR
References: