Mathew S Maurer1, Philip B Adamson2, Maria Rosa Costanzo3, Neal Eigler4, Joanne Gilbert5, Michael R Gold6, Marc Klapholz7, Leslie A Saxon8, Jagmeet P Singh9, Richard Troughton10, William T Abraham11. 1. Columbia University Medical Center, Allen Hospital of New York Presbyterian Hospital, New York, New York. Electronic address: msm10@cumc.columbia.edu. 2. Heart Failure Institute at Oklahoma Heart Hospital and Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; St. Jude Medical, Sylmar, California. 3. Midwest Heart Foundation, Edward Heart Hospital, Naperville, Illinois. 4. Consultant, Global Clinical Affairs, St. Jude Medical, Sylmar, California. 5. St. Jude Medical, Sylmar, California. 6. Medical University of South Carolina, Charleston, South Carolina. 7. Division of Cardiovascular Diseases, Rutgers, The State University of New Jersey-New Jersey Medical School, Newark, New Jersey. 8. Division of Cardiovascular Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California. 9. Harvard Medical School, Cardiology Division, Electrophysiology Laboratory, Cardiac Arrhythmia Service, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 10. Department of Medicine, Christchurch School of Medicine and Health Sciences, Christchurch, New Zealand. 11. Division of Cardiovascular Medicine, Ohio State University, Columbus, Ohio.
Abstract
BACKGROUND: Daily measurements of left atrial pressure (LAP) may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe heart failure (HF). STUDY DESIGN: LAPTOP-HF is a prospective, multicenter, randomized, controlled clinical trial in ambulatory patients with advanced heart failure in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with New York Heart Association functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of ejection fraction, at up to 75 investigational centers. Randomization to the treatment group or control group will be at a 1:1 ratio in 3 strata based on the ejection fraction (EF > or ≤35%) and the presence of a de novo CRT device indication. SUMMARY: LAPTOP-HF will provide essential information about the role of implantable LAP monitoring in conjunction with a new HF treatment paradigm across the spectrum of HF patients.
RCT Entities:
BACKGROUND: Daily measurements of left atrial pressure (LAP) may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe heart failure (HF). STUDY DESIGN: LAPTOP-HF is a prospective, multicenter, randomized, controlled clinical trial in ambulatory patients with advanced heart failure in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with New York Heart Association functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of ejection fraction, at up to 75 investigational centers. Randomization to the treatment group or control group will be at a 1:1 ratio in 3 strata based on the ejection fraction (EF > or ≤35%) and the presence of a de novo CRT device indication. SUMMARY: LAPTOP-HF will provide essential information about the role of implantable LAP monitoring in conjunction with a new HF treatment paradigm across the spectrum of HF patients.
Authors: Leor Perl; Elina Soifer; Jozef Bartunek; Dedi Erdheim; Friedrich Köhler; William T Abraham; David Meerkin Journal: J Cardiovasc Transl Res Date: 2019-01-02 Impact factor: 4.132