William T Abraham1, Michael R Zile2, Fred A Weaver3, Christian Butter4, Anique Ducharme5, Marcel Halbach6, Didier Klug7, Eric G Lovett8, Jochen Müller-Ehmsen9, Jill E Schafer10, Michele Senni11, Vijay Swarup12, Rolf Wachter13, William C Little14. 1. Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: william.abraham@osumc.edu. 2. Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina. 3. Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California. 4. Department of Cardiology, Immanuel Heart Center Bernau - Medical School Brandenburg, Bernau, Germany. 5. Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada. 6. Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany. 7. Department of Cardiology A, University Hospital, Lille, France. 8. Department of Research, CVRx, Inc., Minneapolis, Minnesota. 9. Department of Medicine, Asklepios Klinik Altona, Hamburg, Germany. 10. Department of Statistics, NAMSA, Inc., Minneapolis, Minnesota. 11. Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy. 12. Department of Electrophysiology, Arizona Heart Hospital, Phoenix, Arizona. 13. Clinic for Cardiology and Pneumology, University Medicine Göttingen and German Cardiovascular Research Center, Göttingen, Germany. 14. Division of Cardiology, University of Mississippi Medical Center, Jackson, Mississippi.
Abstract
OBJECTIVES: The objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF. BACKGROUND: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity. METHODS:Patients with New York Heart Association (NYHA) functional class III HF and ejection fractions≤35% on chronic stable guideline-directed medical therapy (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They were randomly assigned to receive ongoing GDMT alone (control group) or ongoing GDMT plus BAT (treatment group) for 6 months. The primary safety end point was system- and procedure-related major adverse neurological and cardiovascular events. The primary efficacy end points were changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance. RESULTS:One hundred forty-six patients were randomized, 70 to control and 76 to treatment. The major adverse neurological and cardiovascular event-free rate was 97.2% (lower 95% confidence bound 91.4%). Patients assigned to BAT, compared with control group patients, experienced improvements in the distance walked in 6 min (59.6 ± 14 m vs. 1.5 ± 13.2 m; p = 0.004), quality-of-life score (-17.4 ± 2.8 points vs. 2.1 ± 3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change in distribution). BAT significantly reduced N-terminal pro-brain natriuretic peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized for HF (p = 0.08). CONCLUSIONS:BAT is safe and improves functional status, quality of life, exercise capacity, N-terminal pro-brain natriuretic peptide, and possibly the burden of heart failure hospitalizations in patients with GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; NCT01720160).
RCT Entities:
OBJECTIVES: The objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF. BACKGROUND: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity. METHODS:Patients with New York Heart Association (NYHA) functional class III HF and ejection fractions ≤35% on chronic stable guideline-directed medical therapy (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They were randomly assigned to receive ongoing GDMT alone (control group) or ongoing GDMT plus BAT (treatment group) for 6 months. The primary safety end point was system- and procedure-related major adverse neurological and cardiovascular events. The primary efficacy end points were changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance. RESULTS: One hundred forty-six patients were randomized, 70 to control and 76 to treatment. The major adverse neurological and cardiovascular event-free rate was 97.2% (lower 95% confidence bound 91.4%). Patients assigned to BAT, compared with control group patients, experienced improvements in the distance walked in 6 min (59.6 ± 14 m vs. 1.5 ± 13.2 m; p = 0.004), quality-of-life score (-17.4 ± 2.8 points vs. 2.1 ± 3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change in distribution). BAT significantly reduced N-terminal pro-brain natriuretic peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized for HF (p = 0.08). CONCLUSIONS: BAT is safe and improves functional status, quality of life, exercise capacity, N-terminal pro-brain natriuretic peptide, and possibly the burden of heart failure hospitalizations in patients with GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; NCT01720160).
Authors: Emanuele Barbato; Paul J Barton; Jozef Bartunek; Sally Huber; Borja Ibanez; Daniel P Judge; Enrique Lara-Pezzi; Craig M Stolen; Angela Taylor; Jennifer L Hall Journal: J Cardiovasc Transl Res Date: 2015-10-09 Impact factor: 4.132