Robert J Mentz1, Adam D DeVore2, Gudaye Tasissa3, John F Heitner4, Ileana L Piña5, Anuradha Lala6, Robert T Cole7, David D Lanfear8, Chetan B Patel9, Mahazarin Ginwalla10, Wayne Old11, Abraham S Salacata12, Robert Bigelow3, Gregg C Fonarow13, Adrian F Hernandez2. 1. Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu. 2. Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. 3. Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC. 4. New York Methodist Hospital, Brooklyn, NY. 5. Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY. 6. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY. 7. Emory University School of Medicine, Atlanta, GA. 8. Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI. 9. Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. 10. Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH. 11. Sentara Cardiovascular Research Institute, Norfolk, VA. 12. Great Lakes Heart Center of Alpena, Alpena, MI. 13. Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, CA.
Abstract
BACKGROUND:Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HF patients. METHODS: PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension). RESULTS: Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05). CONCLUSIONS:Ivabradine initiation prior to discharge among stabilized HF patients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.
RCT Entities:
BACKGROUND:Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HFpatients. METHODS: PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension). RESULTS: Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05). CONCLUSIONS:Ivabradine initiation prior to discharge among stabilized HFpatients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.
Authors: Yee Yin Hoo; Wardati Mazlan-Kepli; Wan Nurul Huda Wan Hasan; Fan Jie Chen; Prashanthini Devadas; Yan Yee Chow; Qian Yi Sow; Azrol Amar Azizan; Abdul Muizz Abd Malek; Glendon Seng Kiong Lau; Ping Lik Chua Journal: J Saudi Heart Assoc Date: 2020-12-03
Authors: Matthew T Mefford; Sandra Y Koyama; Justine De Jesus; Rong Wei; Heidi Fischer; Teresa N Harrison; Pauline Woo; Kristi Reynolds Journal: J Am Heart Assoc Date: 2022-03-24 Impact factor: 6.106