Las Pi?as City, Philippines
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.
Phase
3Span
165 weeksSponsor
AstraZenecaLas Pinas City
Recruiting
iCaReMe Global Registry
The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world.
Phase
N/ASpan
411 weeksSponsor
AstraZenecaLas Pinas City
Recruiting