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

Arrhythmia Clinical Trial

Official title:

Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749307
• Other study ID #: ALFAHRV01
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2008
• Last updated: November 24, 2009
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Dietary Supplement:
• Docosahexaenoic acid (DHA)

• Placebo

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.	Rome	RM

Sponsors (4)

Lead Sponsor	Collaborator
Campus Bio-Medico University	DSM Nutritional Products, Inc., IRCCS San Raffaele, Pharmanutra s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)		basal - 12 weeks - 30 weeks	No