At a glance
ClinicalIndex Comparison Record- ✓Documented diagnosis of stable symptomatic heart failure NYHA class II-III with medical history of typical HF symptoms in those on loop diuretics
- ✓Left ventricular ejection fraction <60% on echocardiogram or cardiac MRI within last 12 months
- ✓eGFR ≥30 and ≤60 mL/min/1.73m² and urine albumin-creatinine ratio ≥30 and <3000 mg/g
- ✓NT-proBNP ≥300 pg/mL for sinus rhythm or ≥600 pg/mL for atrial fibrillation/flutter at screening
- ✕Primary glomerulopathy, vasculitic renal disease, prior dialysis, rapidly progressing renal disease, ADPKD/ARPKD, lupus nephritis, or ANCA-associated vasculitis
- ✕Currently decompensated heart failure requiring hospitalization or not on stable HF therapy at enrollment
- ✕Heart failure due to cardiomyopathies, high-output states, pericardial disease, congenital heart disease, or uncorrected valvular disease
- ✕Type 1 diabetes mellitus or uncontrolled diabetes mellitus (HbA1c >10%)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease
In Brief
A Phase 2 clinical trial evaluating AZD9977 and Dapagliflozin for Heart Failure and Chronic Kidney Disease. Completed, enrolled 153 participants across 156 sites in 22 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF \[below 60%\]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR \[between ≥ 20 and ≤ 60 mL/min/1.73 m\^2, with at least 20% of participants with eGFR ≥ 20 to \<30 mL/min/1.73\^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m\^2\]).
Study Details
Timeline
Interventions
Participants will receive AZD9977 as per the arms they are randomized.
Participants will receive dapagliflozin as per the arms they are randomized.