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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Neuromed IRCCS
Sponsor:
Information provided by (Responsible Party):
Licia Iacoviello, Neuromed IRCCS
ClinicalTrials.gov Identifier:
NCT02045134
First received: January 20, 2014
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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: March 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02045134

Contacts
Contact: Licia Iacoviello, MD, PhD licia.iacoviello@neuromed.it
Contact: Simona Costanzo, MS, PhD simona.costanzo@neuromed.it

Locations
Italy
IRCCS INM Neuromed, Department of Epidemiology and Prevention Not yet recruiting
Pozzilli, IS, Italy, 86077
Contact: Licia Iacoviello, MD, PhD       licia.iacoviello@neuromed.it   
Principal Investigator: Licia Iacoviello, Md, PhD         
Sponsors and Collaborators
Neuromed IRCCS
  More Information

Publications:
Responsible Party: Licia Iacoviello, Laboratory Head, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02045134     History of Changes
Other Study ID Numbers: Neuromed-GR-2008-1146478
Study First Received: January 20, 2014
Last Updated: March 6, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on August 20, 2014