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| Item Type: | Article |
|---|---|
| Title: | Optimized HF therapy in patients with advanced cancer in palliative care: dosing strategies from the EMPATICC trial |
| Creators Name: | Anker, Markus S., Shahzeb Khan, Muhammad, Mahabadi, Amir A., Totzeck, Matthias, Tewes, Mitra, Arshad, Muhammad Sameer, Mincu, Raluca, Butler, Javed, Keller, Ulrich, Ahn, Johann, Bullinger, Lars, Modest, Dominik P., Landmesser, Ulf, Lehmann, Lorenz H., Bercker, Sven, Laufs, Ulrich, Böhm, Michael, Merkely, Bela, Diek, Monika, Heise, Tim, Hellmich, Martin, Placzek, Marius, Friede, Tim, Anker, Stefan D. and Rassaf, Tienush |
| Abstract: | Cardiac wasting occurs in patients with endstage cancer, leading to the development of heart failure (HF)like symptoms characterized by dyspnea, reduced physical function, and diminished quality of life. EMPATICC (EMPower the heArt of patients with TermInal Cancer using Cardiac medicines) is a randomized controlled trial designed to evaluate the impact of optimized HF therapy in patients with advanced cancer receiving specialized palliative care. Given the susceptibility to adverse drug events in this vulnerable population, the trial employed a protocoldriven approach for the initiation and titration of each medication.EMPATICC is a multicenter, randomized, doubleblind, controlled, proofofconcept trial that enrolled 93 patients with stage IV solid tumors (per Union for International Cancer Control [UICC]), under palliative care, with clinical features indicating cardiovascular risk and functional limitation. Participants were randomized 1:1 to receive optimized HF therapy, including sacubitril/valsartan, empagliflozin, ivabradine, and ferric carboxymaltose (FCM), or 14 placebo therapies on top of usual care. All trial medications (or placebo) that was available in tablet form were provided in prepacked containers to support blinding. Blue placebo tablets were used for empagliflozin, white tablets for sacubitril/valsartan, and pink tablets for ivabradine. Blinded staff members did not have access to individual tablet packaging or knowledge of color allocations. Additionally, the meaning of the colorcoded tablets was not disclosed to the blind staff members throughout the trial. Dosing protocols were guided by predefined criteria, including blood pressure, renal function, heart rate, hemoglobin, and body weight, and they were implemented by unblinded staff. Algorithms accounted for prior RAAS inhibitor exposure when initiating sacubitril/valsartan; ensured hemodynamic stability and sinus rhythm for ivabradine; assessed renal reserve when starting empagliflozin to support safe and effective titration; and accounted for body weight and hemoglobin levels when initiating FCM. To ensure consistent implementation across five centers in Germany, visual flowcharts were designed.The EMPATICC trial provides a practical, protocoldriven approach for delivering HF therapy in the palliative oncology setting. Dosing algorithms outlined in this study could serve as a model for structured cardiovascular care in patients with advanced cancer. |
| Keywords: | Heart Failure Therapy, End Stage Cancer, Cardiac Wasting, Clinical Trial |
| Source: | Global Cardiology |
| ISSN: | 2975-2728 |
| Publisher: | PAGE Press |
| Page Range: | 3-9 |
| Date: | 20 August 2025 |
| Official Publication: | https://doi.org/10.4081/cardio.2025.78 |
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