Join Us in Taking Action Now!

The United States Food and Drug Administration (FDA) has not approved any medications for individuals born with single ventricle congenital heart disease (SVHD) who have Fontan circulation. Luckily, the FDA is currently reviewing Udenafil, a medication that is being studied to help improve exercise capacity among patients 12 years of age and older with SVHD and Fontan circulation. If approved, Udenafil will be the only medication available for this specific patient group.

Watch Dr. Goldberg’s Udenafil Updates HERE

On November 19th, 2021, Dr. David Goldberg, co-Principal Investigator of the Fontan Udenafil Exercise Longitudinal Assessment (FUEL) Trial, provided updates on this exciting development. Catch the replay and learn more about this treatment option!

How Can You Help?

Mended Little Hearts would like to invite you to share you and your child’s story with the FDA through our quick 2-3 minute survey. To help you do this, we have developed a few different letter templates that you can access. Within these templates you can share your own story, which could include topics such as:

  • How living with Fontan circulation impacts you and your child’s day to day life, including social activities, sports, school, work, or any other aspect of living
  • The complications your child has faced due to SVHD and Fontan circulation
  • Your child’s goals for how they want to live their life, and the barriers that remain
  • Your child’s experience with Udenafil in the Fontan Udenafil Exercise Longitudinal Open Label Extension (FUEL OLE) study and how Udenafil impacted their life and yours (if applicable)
  • Anything else that you would like to share

Read our letter to the FDA here: Udenafil–Advocacy Addendum Final

Sign on to the letter to have your voice heard by taking our survey here:

Video Creation

Another way to get involved is to create a video testimony. If you would like to have your video testimony submitted to the FDA, record a cellphone video no more than 60 seconds long on what it means to you to have udenafil available as a treatment option. You can send the video to