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

Phase 2

Completed

• Conditions: Arrhythmia
• Interventions: Dietary Supplement: Docosahexaenoic acid (DHA); Dietary Supplement: Placebo

• Registration Number: NCT00749307
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2009-09
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docosahexaenoic acid (DHA)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	basal - 12 weeks - 30 weeks

Trial Locations

Locations (1)

IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.; 🇮🇹 Rome, RM, Italy