https://doi.org/10.55788/67dd5b44
Patients with HF and concomitant CKD have a worse prognosis than those without concomitant CKD, complicating treatment. MR modulators are underused in patients with CKD and are not recommended in patients with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2. “Balcinrenone, previously known as AZD9977, is a selective MR modulator that can separate organ-protective effects from urinary electrolyte excretion,” said Prof. Carolyn Lam (Duke-National University, Singapore) [1]. She presented the results of the phase 2b MIRACLE trial (NCT04595370), which evaluated whether balcinrenone may improve outcomes when added to dapagliflozin in patients with HF and CKD.
Participants with established HF and eGFR 30–60 mL/min/1.73m2 were randomised 1:1:1:1 to dapagliflozin plus placebo or dapagliflozin plus balcinrenone (15 mg, 50 mg, or 150 mg). The primary endpoint was the relative change in urine albumin-creatinine ratio (UACR) from baseline to week 12. Enrolment was terminated early because of slow recruitment, and as a result, the planned sample size was not achieved. The efficacy and safety analyses included 133 and 131 participants, respectively.
The investigators observed reductions in UACR from baseline to week 12 in all balcinrenone arms compared with the placebo arm. Mean percentage change from baseline was −33.61% in the 15 mg group (P=0.1588); −11.83% in the 50 mg group (P=0.6846); and −36.12% in the 150 mg group (P=0.1398). “The reductions in UACR from baseline to week 12 were not significantly different from dapagliflozin alone; there was also no clear dose-response relationship,” Prof. Lam observed.
Safety analyses showed a trend towards a dose-dependent increase in serum potassium. Although hyperkalaemia was rare in this population, 1 participant in the balcinrenone 150 mg group met the hyperkalaemia discontinuation criterion of >6.0 mmol/L serum potassium. There was also a trend towards reduction in eGFR, which was most pronounced in the belcinrenone 150 mg group.
Prof. Lam concluded that further larger studies are needed to decide whether balcinrenone plus dapagliflozin may offer a novel route to beneficial effects of MR modulation in patients with HF and CKD.
- Lam CSP, et al. 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. Late-breaking clinical science: medical therapy, Heart Failure 2024, 11–14 May, Lisbon, Portugal.
Copyright ©2024 Medicom Medical Publishers
Posted on
Previous Article
« Empagliflozin did not reduce mortality for HF after MI regardless of T2D status Next Article
Three diuretic regimens compared in the DEA-HF study »
« Empagliflozin did not reduce mortality for HF after MI regardless of T2D status Next Article
Three diuretic regimens compared in the DEA-HF study »
Table of Contents: HFA 2024
Featured articles
Meet the Trialist: Innovating cardiac monitoring with MONITOR-HF
Trials: Pharmacology
Effects of semaglutide on MACE irrespective of HF status
SEQUOIA-HCM: Aficamten demonstrates clinical efficacy in obstructive HCM
ARIES-HM3 trial: Subgroup analysis in patients with prior need for aspirin
Three diuretic regimens compared in the DEA-HF study
Adding a mineralocorticoid receptor modulator in heart failure with CKD
SGLT2 Inhibitors
Empagliflozin did not reduce mortality for HF after MI regardless of T2D status
SGLT2 inhibitors decrease atrial fibrillation risk in patients with HFrEF
SGLT2 inhibition: Major and early impact on heart failure hospitalisation risk
Trials: Other
Individualised diuretic titration in acute HF without a physician
Intravenous iron deficiency treatment improves exercise capacity in patients with HFpEF
CD34+ stem cells promote reverse cardiac remodelling after acute MI
Registries
Sex-specific outcomes and resource utilisation after HF hospitalisation
Application of guideline-directed medical therapy in patients with HFrEF in the Netherlands
Devices
PAP-guided management system appears safe in patients with HF
Delivery of CRT guided by non-invasive anatomy assessment
RELIEVE-ing HFrEF with interatrial shunting
Miscellaneous
Algorithm-based remote patient monitoring was associated with lower mortality in a retrospective cohort study
High mortality and morbidity in suspected de novo HF in outpatient care
Bio-ADM as a marker for congestion in patients hospitalised for acute HF
Hypertonic saline not effective in ambulatory patients with heart failure?
No effect of low-dose carperitide on mortality or hospitalisation in acute HF
Related Articles
November 5, 2020
Reduced NT-proBNP in HFpEF with sacubitril/valsartan
October 26, 2021
2021 ESC Guidelines on Heart Failure
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy
HEAD OFFICE
Laarderhoogtweg 25
1101 EB Amsterdam
The Netherlands
T: +31 85 4012 560
E: publishers@medicom-publishers.com