Rationale and Design of the Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF).
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).


METHODS
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.


CONCLUSIONS
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.
Columbia University Medical Center, Allen Hospital of New York Presbyterian Hospital, New York, New York. Electronic address: msm10@cumc.columbia.edu.
Mathew S
MS
Maurer
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.
Philip B
PB
Adamson
Midwest Heart Foundation, Edward Heart Hospital, Naperville, Illinois.
Maria Rosa
MR
Costanzo
Consultant, Global Clinical Affairs, St. Jude Medical, Sylmar, California.
Neal
N
Eigler
St. Jude Medical, Sylmar, California.
Joanne
J
Gilbert
Medical University of South Carolina, Charleston, South Carolina.
Michael R
MR
Gold
Division of Cardiovascular Diseases, Rutgers, The State University of New Jersey-New Jersey Medical School, Newark, New Jersey.
Marc
M
Klapholz
Division of Cardiovascular Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California.
Leslie A
LA
Saxon
Harvard Medical School, Cardiology Division, Electrophysiology Laboratory, Cardiac Arrhythmia Service, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Jagmeet P
JP
Singh
Department of Medicine, Christchurch School of Medicine and Health Sciences, Christchurch, New Zealand.
Richard
R
Troughton
Division of Cardiovascular Medicine, Ohio State University, Columbus, Ohio.
William T
WT
Abraham
D000328:Adult; D062185:Atrial Pressure; D006328:Cardiac Catheterization / Q000379:methods; D058406:Cardiac Resynchronization Therapy / Q000379:methods; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D005260:Female; D006325:Heart Atria / Q000503:physiopathology; D006333:Heart Failure / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods; D020097:Natriuretic Peptide, Brain / Q000097:blood; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012648:Self Care / Q000295:instrumentation / Q000379:methods; D012720:Severity of Illness Index; D013318:Stroke Volume
D002317:Cardiovascular Agents; D020097:Natriuretic Peptide, Brain
Heart failure; hemodynamic monitoring; left atrial pressure; patient self-management; physician-directed