BaxDuo Prevent-HF
Research type
Research Study
Full title
A Phase III, Randomised, Double-Blind, Placebo-controlled, Event driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure
IRAS ID
1010949
Contact name
Nicola Dee
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-514506-32
Research summary
Researchers are looking for a better way to reduce development of heart failure and reduce the risk of death from cardiovascular causes in patients with history of cardiovascular disease, high blood pressure and type 2 diabetes (T2D). Heart failure is a condition where heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms such as tiredness, shortness of breath, swelling of the legs and ankles, chest pain and a cough. In this trial researchers are looking into how well a drug called baxdrostat works and how safe it is when combined with drug called dapagliflozin in patients at an increased risk of developing heart failure.
Dapagliflozin is an approved medication to help people with kidney disease with or without T2D. It changes how the kidneys handle sugar, salt, and water, which helps heart and kidneys health. In the present study, all participants will be provided dapagliflozin. Baxdrostat blocks production of hormone aldosterone in the body, helps reduce extra salt and fluid retention in the body and lowers blood pressure and may also reduce the risk of developing heart failure. Researchers want to learn if taking baxdrostat with dapagliflozin could help reduce risk of heart failure and cardiovascular deaths than taking dapagliflozin with a placebo. The placebo will look like baxdrostat but will not have any medicine in it. This trial will include up to about 11,300 participants globally. To join people must be 40 years of age or older and have prior history of cardiovascular disease (prior heart attack or stroke) and T2D with high blood pressure. Participants already taking dapagliflozin or a similar drug (called SGLT2i) will be randomly put in either treatment (Baxdrostat) or placebo arm while also receiving dapagliflozin. Participants who are not already taking dapagliflozin will begin the trial by taking dapagliflozin for 4 weeks before being randomised in the study. The average study duration is approximately 38 months.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0020
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion