Browsing by Author "Böhm, Michael"

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    Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study
    (Elsevier, 2021) Felker, G. Michael; McMurray, John J. V.; Cleland, John G.; O’Connor, Christopher M.; Teerlink, John R.; Voors, Adriaan A.; Belohlavek, Jan; Böhm, Michael; Borentain, Maria; Bueno, Hector; Cole, Robert T.; DeSouza, Mary M.; Ezekowitz, Justin A.; Filippatos, Gerasimos; Lang, Ninian N.; Kessler, Paul D.; Martinez, Felipe A.; Mebazaa, Alex; Metra, Marco; Mosterd, Arend; Pang, Peter S.; Ponikowski, Piotr; Sato, Naoki; Seiffert, Dietmar; Ye, June; Emergency Medicine, School of Medicine
    Objectives: The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were to identify signals of efficacy, including biomarkers, symptoms, and clinical events. Background: Nitroxyl (HNO) donors have vasodilator, inotropic and lusitropic effects. Bristol-Myers Squibb-986231 (cimlanod) is an HNO donor being developed for acute heart failure (AHF). Methods: This was a phase IIb, double-blind, randomized, placebo-controlled trial of 48-h treatment with cimlanod compared with placebo in patients with left ventricular ejection fraction ≤40% hospitalized for AHF. In part I, patients were randomized in a 1:1 ratio to escalating doses of cimlanod or matching placebo. In part II, patients were randomized in a 1:1:1 ratio to either of the 2 highest tolerated doses of cimlanod from part I or placebo. The primary endpoint was the rate of clinically relevant hypotension (systolic blood pressure <90 mm Hg or patients became symptomatic). Results: In part I (n = 100), clinically relevant hypotension was more common with cimlanod than placebo (20% vs. 8%; relative risk [RR]: 2.45; 95% confidence interval [CI]: 0.83 to 14.53). In part II (n = 222), the incidence of clinically relevant hypotension was 18% for placebo, 21% for cimlanod 6 μg/kg/min (RR: 1.15; 95% CI: 0.58 to 2.43), and 35% for cimlanod 12 μg/kg/min (RR: 1.9; 95% CI: 1.04 to 3.59). N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation. Conclusions: Cimlanod at a dose of 6 μg/kg/min was reasonably well-tolerated compared with placebo. Cimlanod reduced markers of congestion, but this did not persist beyond the treatment period.
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    Renal Denervation Update From the International Sympathetic Nervous System Summit: JACC State-of-the-Art Review
    (Elsevier, 2019-06-18) Kiuchi, Márcio G.; Esler, Murray D.; Fink, Gregory D.; Osborn, John W.; Banek, Christopher T.; Böhm, Michael; Denton, Kate M.; DiBona, Gerald F.; Everett, Thomas H., IV.; Grassi, Guido; Katholi, Richard E.; Knuepfer, Mark M.; Kopp, Ulla C.; Lefer, David J.; Lohmeier, Thomas E.; May, Clive N.; Mahfoud, Felix; Paton, Julian F.R.; Schmieder, Roland E.; Pellegrino, Peter R.; Sharabi, Yehonatan; Schlaich, Markus P.; Medicine, School of Medicine
    Three recent renal denervation studies in both drug-naïve and drug-treated hypertensive patients demonstrated a significant reduction of ambulatory blood pressure compared with respective sham control groups. Improved trial design, selection of relevant patient cohorts, and optimized interventional procedures have likely contributed to these positive findings. However, substantial variability in the blood pressure response to renal denervation can still be observed and remains a challenging and important problem. The International Sympathetic Nervous System Summit was convened to bring together experts in both experimental and clinical medicine to discuss the current evidence base, novel developments in our understanding of neural interplay, procedural aspects, monitoring of technical success, and others. Identification of relevant trends in the field and initiation of tailored and combined experimental and clinical research efforts will help to address remaining questions and provide much-needed evidence to guide clinical use of renal denervation for hypertension treatment and other potential indications.