Omega-3 Fatty Acids and Cardiovascular Disease in Hemodialysis

Event Details

Purpose

The purpose of this NIH workshop, Omega-3 Fatty Acids and Cardiovascular Disease in Hemodialysis, is to convene multidisciplinary stakeholders to discuss the current evidence and key methodological considerations for replication trials of omega-3 fatty acid (fish oil) therapy in individuals receiving maintenance hemodialysis.

The workshop will bring together investigators, patients, clinicians, trialists, and federal partners to examine issues related to trial design, endpoints, product formulation, adherence assessment, safety, recruitment, and implementation considerations for future U.S.-based studies. Emphasis will be placed on strengthening capacity for replication trial design and identifying priorities for rigorous studies addressing cardiovascular (CV) outcomes in the hemodialysis (HD) population.

Through presentations and interactive discussions, the workshop aims to identify knowledge gaps, foster collaboration, and inform future research directions related to omega-3 fatty acid therapy in hemodialysis.

Objectives

1. Enhance workforce capacity for replication trials considering methodology options and examples, with particular relevance to objective
2. Deliberate on key components for a fish oil replication trial in HD in the United States.

Planning Committee

NIDDK: Afshin Parsa, Kevin Chan, Susan Mendley, Kayla Hurd, Debbie Gipson
OD/Office of Dietary Supplements: Adam Kuszak
NCCIH: Wendy Weber
NHLBI: Robert Shamburek

Registration Deadline

August 4, 2026

Agenda

Day 1: August 3, 2026

12:30 p.m. – 12:45 p.m.

Welcome and Objectives for the Workshop

12:45 p.m. – 1:15 p.m.

Trial of Fish Oil in HD (e.g., PISCES Lok, 2025)
Presentation 20 minutes; Discussion 10 minutes

1:15 p.m. – 1:40 p.m.

Replication Trial Methodologies and Examples
Presentation 20 minutes; Discussion 5 minutes

1:40 p.m. – 2:15 p.m.

Panel: Patient Perspectives

2:15 p.m. – 2:45 p.m.

Discussion: Considerations for Replication Trial of Fish Oil in HD

2:45 p.m. – 3:00 p.m.

Break

3:00 p.m. – 3:30 p.m.

Polyunsaturated Fatty Acids in Prevention of CV Events
Presentation 15 minutes; Q&A 15 minutes

3:30 p.m. – 4:15 p.m.

Lipidomics of Fish Oil and Implications for Product Formulation, Assay for Adherence, and Safety
Presentation 15 minutes; Discussion 30 minutes

4:15 p.m. – 4:30 p.m.

FDA Drug Versus Supplement

4:30 p.m. – 5:00 p.m.

Who and Where: U.S. HD Population and CV Event Management Care Pathways
Presentation 10 minutes; Discussion 20 minutes

5:00 p.m. – 5:15 p.m.

Wrap-up

5:15 p.m.

Adjourn for the Day

Networking dinner on your own

Day 2: August 4, 2026

8:00 a.m. – 8:30 a.m.

Meeting Rooms Open for Networking

8:30 a.m. – 8:45 a.m.

Welcome and Brief Highlights of Day 1

8:45 a.m. – 9:15 a.m.

Endpoints: CV and Mortality Endpoints, Ascertainment, and Adjudication

9:15 a.m. – 10:00 a.m.

Ascertainment of Participant Perspectives and Adherence to Nutritional Supplements
Presentation 15 minutes; Discussion 30 minutes

10:00 a.m. – 10:30 a.m.

Discussion: Sample Size and Power Considerations in Replication Trials

10:30 a.m. – 10:45 a.m.

Break and Networking

10:45 a.m. – 11:30 a.m.

Discussion: Recruitment Strategies and On-trial Monitoring Approaches

11:30 a.m. – 12:15 p.m.

Payer Perspective: Enablers and Barriers to Formulary Additions

12:15 p.m. – 12:30 p.m.

Wrap-up and Next Steps

12:30 p.m.

Adjournment