Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Not Recruiting

Trial ID: NCT01121107


The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).

Official Title

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

Stanford Investigator(s)

Natalya Hasan-Hill
Natalya Hasan-Hill

Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine


Inclusion Criteria:

   - Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or
   preserved ejection fraction and heart failure for at least 6 months.

   - NYHA Class III documented at screening visit.

   - Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines
   (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin
   receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the
   randomization visit. Subject has been on stable medications maximized to the subject's
   tolerance of ACE or ARB and beta-blockers as determined by the study investigator for
   at least 30 days prior to randomization. Stable is defined as no more than a 100%
   increase or 50% decrease in dose. These criteria may be waved if a subject is
   intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the
   Guidelines. Such intolerance or lack of indications must be documented.

   - Have a minimum of one (1) prior hospital admission within the last 12 months for acute
   exacerbation of HF of at least one (1) calendar date change duration requiring
   intravenous or invasive HF therapy. If CRT device previously implanted, the heart
   failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if
   patients have not had a heart failure hospitalization within the prior 12 months, they
   must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an
   N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local
   measurement at the time of screening (within 30 days of the screening visit/consent)

   - Provide informed consent for study participation and be willing and able to comply
   with the required tests, treatment instructions and follow-up visits.

   - Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may
   be delayed until this criterion is met.

Exclusion Criteria:

   - Are under the age of 18 years.

   - Are pregnant.

   - Have intractable HF with resting symptoms despite maximal medical therapy (persistent
   NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or
   intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV
   vasodilators), patients treated with a ventricular assist device (VAD), and patients
   who have received a cardiac transplant or are listed for cardiac transplantation and
   likely to be transplanted within 12 months - even if their functional status has
   improved to NYHA Class III. Patients listed for cardiac transplantation who are not
   likely to be transplanted within 12 months and who have improved to NYHA Class III
   without outpatient IV vasoactive medications or a VAD are eligible for the study, if
   they meet the other inclusion/exclusion criteria.

   - Have a resting systolic blood pressure < 80 or > 180 mmHg.

   - Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI),
   new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision,
   lead extraction or cardiac or other major surgery within 40 days.

   - Have known coexisting, untreated, hemodynamically severe stenotic valve lesions,
   vegetations, hypertrophic cardiomyopathy with significant resting or provoked
   subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion.

   - Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on
   color Doppler or intravenous bubble study) or surgical correction of significant
   congenital heart disease involving atrial septum such as PFO or ASD closure device.

   - Have a Stroke or Transient Ischemic Attack within 6 months.

   - Have inadequate vascular access for device implantation.

   - Have baseline 2-D echocardiographic evidence of, or history of, unresolved left atrial
   or ventricular thrombus.

   - Have a recent (within 6 months) or persistent deep venous thrombosis, pulmonary or
   systemic thromboembolism.

   - Have a life expectancy < 1 year due to another illness.

   - Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for
   all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.

   - Have an Estimated Glomerular Filtration Rate that remains < 30 ml/min/1.73 M2 by the
   MDRD method.

   - Have a Liver Function Test > 3 times upper limit of normal.

   - Have Severe Pulmonary Disease producing frequent hospitalizations for respiratory
   distress and requiring continuous home oxygen.

   - Have pulmonary hypertension with a pulmonary artery systolic pressure of greater than
   or equal to 80 mm/Hg on screening echocardiogram.

   - Have an active infection requiring systemic antibiotics.

   - Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital
   admission for psychosis within the prior 2 years.

   - Are currently participating in a clinical investigation that includes an active
   treatment arm.

   - Are unable to demonstrate understanding and capability of using the PAM patient
   advisory module appropriately.

   - Patient does not have access to a telephone line usable for remote PAM follow-up or
   electrical outlet for recharging PAM.


device: Left Atrial Pressure Monitoring System

device: Patient Advisory Module

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305