Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery (Polyphemus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Neuromed IRCCS
Information provided by (Responsible Party):
Licia Iacoviello, Neuromed IRCCS Identifier:
First received: January 20, 2014
Last updated: September 23, 2014
Last verified: September 2014

Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Epidemiological studies show a significant inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic components. The main objective of this study is to evaluate the effect of polyphenol-rich food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or repaired (VR))

Condition Intervention
Cardiac Surgery
Dietary Supplement: Placebo
Dietary Supplement: High-anthocyanin rich corn flour

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Neuromed IRCCS:

Primary Outcome Measures:
  • Post Operative Atrial Fibrillation [ Time Frame: up to 10 days after cardiac surgery ] [ Designated as safety issue: Yes ]
    Reduction of Post Operative Atrial Fibrillation after a cardiac surgery

Secondary Outcome Measures:
  • intensive unit and post-operative hospital-stay [ Time Frame: up to hospital discharge (average period 10 days) ] [ Designated as safety issue: No ]
    reduction of intensive unit and post-operative hospital-stay

  • cumulative post-operative complications [ Time Frame: up to 30 days after cardiac surgery ] [ Designated as safety issue: No ]
    reduction of occurrence of cumulative post-operative complications (renal failure, pulmonary failure (time frame: up to hospital discharge); fatal and non-fatal cardiovascular events and all-causes mortality) (time frame: up to 30 days after cardiac surgery)

  • circulating inflammatory markers [ Time Frame: up to 24 hours after cardiac surgery ] [ Designated as safety issue: No ]
    additional end-point will be circulating inflammatory markers such as C reactive protein (CRP), interleukin 6 (IL6), D-dimers, plasma proteome

Estimated Enrollment: 350
Study Start Date: September 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Soluble corn flour not rich in anthocyanins
Dietary Supplement: Placebo
Soluble corn flour not rich in anthocyanins
Active Comparator: High-anthocyanin rich corn flour
Soluble corn flour at high content in anthocyanins
Dietary Supplement: High-anthocyanin rich corn flour
Soluble corn flour at high content in anthocyanins

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • presence of sinus rhythm on the screening electrocardiogram
  • first-time elective open heart surgery

Exclusion Criteria:

  • absence of sinus rhythm at screening
  • known allergy or intolerance to gluten or anthocyanin compound
  • regularly consuming of anthocyanin or antioxidant supplements,
  • being currently pregnant,
  • existing or planned cardiac transplant or use of ventricular assist device,
  • being unable or unwilling to provide informed consent,
  • history of hepatic or renal disease,
  • history of cancer history of substance abuse
  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 identifier: NCT02045134

Contact: Licia Iacoviello, MD, PhD
Contact: Simona Costanzo, MS, PhD

IRCCS INM Neuromed, Department of Epidemiology and Prevention Recruiting
Pozzilli, IS, Italy, 86077
Contact: Licia Iacoviello, MD, PhD   
Principal Investigator: Licia Iacoviello, Md, PhD         
Sponsors and Collaborators
Neuromed IRCCS
  More Information

Responsible Party: Licia Iacoviello, Laboratory Head, Neuromed IRCCS Identifier: NCT02045134     History of Changes
Other Study ID Numbers: Neuromed-GR-2008-1146478
Study First Received: January 20, 2014
Last Updated: September 23, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on March 26, 2015