Assessment of a diuretic optimization protocol in non-selected acute worsening HF — the ProDUCT-HF study: A stepped-wedge cluster-randomized trial - 08/01/26
, G. Clerfond 1, B. Pereira 2, P. Rossignol 3, G. Vanzetto 4, H. Barake 5, B. Harbaoui 6, P.-Y. Courand 6, L. Flork 7, S. Madi 8, O. De Tauriac 9, Y. Nahli 10, M. Chacornac 11, C. Mourgues 2, K. Francis 1, N. Combaret 1, G. Souteyrand 1, P. Motreff 1, G. Massoullie 1, R. Eschalier 1Résumé |
Introduction |
Acute worsening heart failure (AWHF) is a major medical issue in the history of chronic HF. Use of intra-venous diuretics is the keystone of this management, but sparse data are available in non-selected HF population. In this setting, the use and impacts of diuretics, need to be better evaluated to improve their efficacy and safety in the latter population.
Objective |
To show benefit of a diuretic protocol combining furosemide and thiazid in AWHF.
Method |
The Protocol of Diuretic's Use in Congestive Therapy for Heart Failure (ProDUCT-HF) study is a French multicenter, prospective, stepped-wedge cluster-randomized trial (CW-CRT) comparing pre-protocolized diuretics use based on CARRESS-HF's study protocol to routine practice diuretics use in AWHF. The primary endpoint was change-from-admission at day 4 in a bivariable endpoint: serum creatinine and bodyweight. Delta ePVS, approach of volemia, are analysed at day 4 comparing to admission. All analysis were led as modified intention-to-treat.
Results |
Between May 2019 and December 2022, 271 patients were randomized in two group. At 96 hours, the median change in the weight was more important in the protocol group (−4.9 kg [−7.8; −2.9] vs. (−3.6 kg [−5.6; −2.0]) in the SoC group, (OR −1.1 [−2.1 to −0.2], P = 0.020). The median change of serum creatinine at 96 hours was greater in the protocol group (+13 μmol/L [−2; 37] vs. (+8 μmol/L [−6; 20]), (OR 12.7 [4.1 to 21.3], P = 0.004) ( Fig. 1 ). Decongestion (evaluated by Delta ePVS) was improved in the protocol group (−0.81 [−3.03; 1.08] vs. (0.00 [−1.51; 1.97]), (OR −1.1 [−1.8 to −0.4], P = 0.004). The median duration of intravenous furosemide treatment and one-month endpoints (all cause death, GFR, NTproBNP) were similar in both groups.
Conclusion |
The ProDUCT-HF diuretics protocol is relevant to obtain a good decongestion with a good safety profile in non-selected AWHF population ( NCT03892148 ).
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Vol 119 - N° 1S
P. S33-S34 - janvier 2026 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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