Phase 2/3 Study of Vericiguat in Paediatric HF due to LVSD

• Research type

  Research Study

• Full title

  A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

• IRAS ID

  1006620

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2021-004399-33

• Clinicaltrials.gov Identifier

  NCT05714085

• Research summary

  Heart failure (HF) is a serious disease that not only affects the quality of life of a person but also raises the chance of hospitalisation and death. In HF, the heart does not pump enough blood to the body. Most of the current treatments used for HF in children are approved for HF in adults. Doctors use these treatments in children because HF in children is likely to be similar to HF in adults. Past studies in adults found that vericiguat lowered the chance of hospitalisation and death from HF. Vericiguat is approved for adults with HF.
  In this study, researchers want to learn if vericiguat lowers the severity of HF in children based on a blood test called NT-proBNP. NT-proBNP measures the blood level of a protein that the heart makes during HF. Blood levels of NT-proBNP go up when HF gets worse and go down when HF is controlled.
  About 342 children aged 28 days to less than 18 years of age with chronic (long-lasting) HF will be in this study, participating for up to 58 weeks. Children will be assigned by chance to take vericiguat or a placebo once a day for 52 weeks in addition to their current treatment for HF.
  Children will undergo procedures such as blood samples, an electrocardiogram (ECG) and bone x-rays. Children older than 6 years old will also have hearing tests.
  The starting dose (amount) and formulation (tablet or liquid) of vericiguat will depend on the child’s weight. The dose will go up 1 or 2 times during the study depending on the child’s blood pressure. Researchers will stop or lower a child’s dose of vericiguat if they have low blood pressure.

  The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  22/LO/0807

• Date of REC Opinion

  5 Dec 2022

• REC opinion

  Further Information Favourable Opinion