Cinaciguat (BAY 58–2667) Improves Cardiopulmonary Hemodynamics in Patients With Acute Decompensated Heart Failure
Abstract
Background— Cinaciguat (BAY 58–2667) is the first of a new class of soluble guanylate cyclase activators in clinical development for acute decompensated heart failure. We aimed to assess the hemodynamic effects, safety, and tolerability of intravenous cinaciguat in patients with acute decompensated heart failure (pulmonary capillary wedge pressure ≥18 mm Hg). Methods and Results— After initial dose finding (part A; n=27), cinaciguat was evaluated in the nonrandomized, uncontrolled proof-of-concept part of the study (part B; n=33) using a starting dose of 100 μg/h, which could be titrated depending on hemodynamic response. Patients were categorized as responders if their pulmonary capillary wedge pressure decreased by ≥4 mm Hg compared with baseline. Final doses of cinaciguat after 6 hours of infusion in part B were 50 μg/h (n=2), 200 μg/h (n=12), and 400 μg/h (n=16). Compared with baseline, a 6-hour infusion of cinaciguat led to significant reductions in pulmonary capillary wedge pressure (−7.9 mm Hg), mean right atrial pressure (−2.9 mm Hg), mean pulmonary artery pressure (−6.5 mm Hg), pulmonary vascular resistance (−43.4 dynes · s · cm −5 ), and systemic vascular resistance (−597 dynes · s · cm −5 ), while increasing heart rate by 4.4 bpm and cardiac output by 1.68 L/min. The responder rate was 53% after 2 hours, 83% after 4 hours, and 90% after 6 hours. Cinaciguat was well tolerated, with 13 of 60 patients reporting 14 drug-related treatment-emergent adverse events of mild to moderate intensity, most commonly hypotension. Conclusions— Cinaciguat has potent preload- and afterload-reducing effects, increasing cardiac output. Further investigation of cinaciguat for acute decompensated heart failure is warranted.
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- Authors
- Lapp, H., Mitrovic, V., Franz, N., Heuer, H., Buerke, M., Wolfertz, J., Mueck, W., Unger, S., Wensing, G., & Frey, R.
- Affiliations
- Helios Universitätsklinikum Wuppertal (DE)
- From HELIOS Clinic Erfurt, Erfurt, Germany (H.L.); Kerckhoff Clinic Nauheim, Bad Nauheim, Germany (V.M.); Schüchtermann Clinic Bad Rothenfelde, Bad Rothenfelde, Germany (N.F.); St Johannes Hospital Dortmund, Dortmund, Germany (H.H.); University of Halle, Halle, Germany (M.B.); HELIOS Clinic Wuppertal, Wuppertal, Germany (J.W.); and Clinical Pharmacology (W.M., G.W., R.F.) and Global Biostatistics (S.U.), Bayer HealthCare AG, Pharma Research Center, Wuppertal, Germany.
- Venue
- Circulation
- Published
- 2009-06-02
- Volume
- 119
- Issue
- 21
- Pages
- 2781-2788
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2149641204
- Cited by
- 148
- References
- 31
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 3 · 2023: 3 · 2022: 8 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 8 · 2017: 8 · 2016: 8 · 2015: 8 · 2014: 7 · 2013: 13 · 2012: 21
- FWCI
- 12.83
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bayer HealthCare
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Pulmonary Hypertension Research and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- cinaciguat, BAY 58-2667, soluble guanylate cyclase activator, acute decompensated heart failure, cardiopulmonary hemodynamics, pulmonary capillary wedge pressure, pulmonary vascular resistance, systemic vascular resistance, cardiac output, drug safety and tolerability, hypotension
- MeSH terms
- Soluble Guanylyl Cyclase, Acute Disease, Adult, Aged, Aged, 80 and over, Benzoates, Blood Pressure, Cardiac Output, Enzyme Activation, Female, Guanylate Cyclase, Heart Failure, Heart Rate, Hemodynamics, Humans, Hypotension, Infusions, Intravenous, Male, Middle Aged, Pulmonary Wedge Pressure, Vascular Resistance, Vasodilator Agents, Receptors, Cytoplasmic and Nuclear
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