Heart Failure Trials ⚖️ Therapies 💊 FDA Decisions 📜
Dr RR Baliga's "Got Knowledge Doc" Podkast
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Show Notes
🚨 New in JACC (Aug 2025): Evidentiary Landscape of HF Therapies 🫀
Over the last decade, the heart failure field has shifted from the "mortality reduction era" (ACEIs, β-blockers, MRAs) ➡️ to the "hospitalization reduction era" (SGLT2i, ARNI in HFpEF, iron therapy).
🔑 Key Insights:
⚖️ FDA decisions reflect both rigor and flexibility — approving sacubitril/valsartan in HFpEF despite a missed primary endpoint, while rejecting omecamtiv mecarbil despite statistical significance.
🧬 Enrichment strategies (NT-proBNP, iron indices, recent WHF) drive modern trial design, boosting efficiency but limiting mortality signals.
📊 Composite endpoints (CV death + HHF) dominate, making hospitalization reduction the most reproducible outcome.
📖 Guidelines now anchor on ARNI + SGLT2i in HFrEF and SGLT2i in HFpEF, with emerging roles for finerenone and incretin-based therapies.
👉 Big picture: Clinical practice is evolving, but the "holy grail" of new mortality-reducing therapies remains elusive.
#HeartFailure #Cardiology #ClinicalTrials #FDA #JACC