Public Meeting: Endpoints for Drug Development in Heart Failure

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FDA White Oak Conference Center

10903 New Hampshire Avenue

Building 31

Silver Spring, MD 20903

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Event description


Meeting Background:

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled “Endpoints for Drug Development in Heart Failure." The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.

Topics for Discussion:

FDA is interested in soliciting feedback on a number of topics:

  1. Consider and discuss endpoints related to symptoms and physical function, e.g., patient-reported outcome instruments, exercise tests, data from electronic monitors;

  2. Consider the best ways to count multiple hospitalizations;

  3. Discuss when the nature and clinical importance of a treatment effect for a particular endpoint may justify deferral or omission of outcomes studies;

  4. In setting an upper bound for a mortality risk to be ruled-out, discuss how the boundary may be influenced by a drug’s demonstrated benefits and risks;

  5. Discuss the advantages and disadvantages of all-cause vs. cardiovascular-specific endpoints, e.g., hospitalizations and deaths;

  6. Discuss the advantages and disadvantages of adjudicating causes of deaths and hospitalizations.

Onsite Registration and Check-In:

8 AM - 9 AM

(Note: Online registration is strongly encouraged, seats may be limited)

Federal Register Notice:

Docket Number: FDA-2019-N-2452


Meeting Agenda:

7:45 am Registration opens

8:45 am Welcome and Overview, Background (5 mins)
- Ellis Unger

8:50 am Opening Remarks (5 mins)
Norman Stockbridge

8:55 am HFSA/FDA Survey Results (5 mins)
Mona Fiuzat

9:00 am HFSA Statement (5 mins)
Randall Starling, HFSA President

9:05 am Part I: Endpoints related to symptoms or physical function of clinical importance in HF (75 mins)

- Moderator: JoAnn Lindenfeld

QOL, symptoms, PRO’s (15 mins)
- Eldrin Lewis

Functional Endpoints: 6MW, accelerometer, new technologies (15 min)
- Bill Abraham

Quantifying Hospitalization? (15 min)
- John Teerlink

Reactants and Panel Discussion (30 mins):

Panelist – Mary N. Walsh
Panelist – Paul Heidenreich
Panelist – Patient– Skype in Reiss Tatum
Panelist – Patient – Skype in Cynthia Chauhan
Panelist – Biykem Bozkurt
Panelist – Ellis Unger

10:25 am Break (15 mins)

10:45 am Part II: Mortality and Outcomes (85 mins)
- Moderator: Chris O’Connor

When would deferral or omission of outcomes studies be justified? (20 mins)
- Scott Solomon

What is the risk of mortality that should be ruled out? (20 mins)
- John McMurray

Reactants and Panel Discussion (45 mins):

Panelist - Michael Felker
Panelist - Javed Butler
Panelist – Lynne Stevenson
Panelist – Patient – Rhonda Monroe
Panelist - Norman Stockbridge

12:05 pm Lunch (60 mins)

1:10 pm Part III: All-cause vs. cause-specific events, Adjudication (60 mins)
- Moderator: Clyde Yancy

Should all-cause or cause-specific events be used? (15 mins)
- Christopher O’Connor

Should the FDA require adjudication of cause-specific events? (15 mins)
Michael Bristow

Reactants and Panel Discussion (30 mins):

Panelist – JoAnn Lindenfeld
Panelist – Peter Carson
Panelist – John Teerlink
Panelist – Robert Temple

2:15 pm Open Audience Feedback (1 hr. 45 mins)
- Moderators: Chris O’Connor, JoAnn Lindenfeld, Clyde Yancy

The audience is invited to share remarks and outstanding questions regarding the day’s
discussion and FDA’s draft guidance “Treatment of Heart Failure: Endpoints for Drug Development”.

4:00 pm Closing Remarks and Adjournment

(Only printed copies of the agenda, affiliations, and disclosures will be provided during the meeting)

Requests for Oral Comments:

On the day of the meeting, a sign-up sheet will be made available for those who wish to speak during the public comment session. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments. On the meeting day, based on demand, we will determine the amount of time allotted to each presenter and the approximate time each comment is to begin.

Please note this will be oral comment only; no slides or other presentation material is permitted. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Online Attendance via Webcast:

FDA will provide a free-of-charge, live webcast for this workshop. On the day of the meeting, click the following link to attend:

If you have never attended a Connect Pro event before, test your connection at To get a quick overview of the Connect Pro program, visit FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.


Once available, the transcript will be posted after the workshop date at and Approximately 60 - 90 days after the meeting.

Assistance with Special Accommodations

If you need special accommodations due to a disability and/or need more information regarding this meeting, please contact Meg Pease-Fye no later than July 1, 2019, via email at or by phone at (301) 796-2240.

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FDA White Oak Conference Center

10903 New Hampshire Avenue

Building 31

Silver Spring, MD 20903

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