Sanger Heart & Vascular Institute is involved in several national clinical trials that benefit patients with heart failure. We are currently enrolling patients in the following studies:
IDENTIFY-HF: Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Of the 5 million patients in the United States with heart failure, about 50 percent experience diastolic heart failure, where the heart's ventricles become stiff and do not allow enough blood flow back to the heart, which causes a backup of blood in the lungs. And of that 50 percent, 20 percent have atrial fibrillation as well, which causes irregular impulses to the ventricles.
Sanger Heart & Vascular Institute is one of approximately 12 sites in the United States to look at 100 nondevice heart failure patients with diagnostics and monitoring in order to determine which patients are at the greatest risk of decompensation.
The purpose of the study is to validate a heart failure risk status algorithm in a diastolic heart failure population and to obtain pilot data regarding the potential of such a risk status score to help improve patient outcomes.
Patients, ages 18 or older, with the following can be included in the IDENTIFY-HF study:
- documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e., palpitations)
- patient is indicated for or has an existing implantable cardiac monitor
- recent HF clinic/ER visit with IV diuretics or HF hospitalization (within prior 90 days)
- LVEF ≥ 40 percent by echo within previous six months (if myocardial infarction (MI) within past six months, echo must be performed within the last 30 days and also must be at least 30 days after MI)
LAPTOP-HF: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
LAPTOP-HF is testing a new method of treatment for heart failure patients using left atrial pressure combined with physician direction and patient self-management to reduce heart failure-related hospitalizations. The trial is designed to adjust a patient's medications before he or she develops symptoms or requires hospitalization. This is done by measuring ressure in the heart from an implanted device similar to a pacemaker. Readings are then transferred to a handheld device that provides daily recommended medications and dosages and reminds patients to take their medications.
The handheld device, known as a patient advisor module (PAM), allows patients to record how they are feeling. Information from the implanted device downloads onto the PAM and periodically transmits to the physician's office over a telephone line. The physician can then use a computer to check the patient's heart performance and provide the medication and doses the patient should be taking. That information is then sent back to the PAM with further medical instructions.
Patients must meet the following criteria to be included in this trial:
- ischemic or nonischemic cardiomyopathy for at least six months
- HYHA Class III symptoms at baseline
- receiving maximal tolerated stable medical therapy per ACC/AHA guidelines
- minimum of one prior HF hospital admission within the last 12 months
If you would like to refer a patient for enrollment in the LAPTOP-HF trial, call 704-355-4794.