Phase 3 Clinical Trial shows promise for LAPTOP-HF care: 6/1

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Phase 3 Clinical Trial shows promise for LAPTOP-HF care

Two MUSC doctors hope results from a 75-site, multinational clinical trial will confirm a promising new treatment for patients hoping to prevent congestive heart failure.

MUSC's Michael Craig, M.D., and Frank Cuoco, M.D., serve as principal investigators for the phase 3 Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF) trial. The St. Jude Medical-manufactured device for measuring left atrial pressure tested in this trial could change the way heart failure is managed by providing real-time management of heart failure-related congestion.

The device helps doctors prevent the peaks and valleys in left atrial pressure by closely monitoring the subtle hemodynamic changes in the heart so that doctors can quickly adjust medication to ward off when a patient may be at risk for the congestive symptoms of too much fluid and of organ damage from too little blood flow to the organs.

Craig said a little prevention can go a long way, especially given that congestive symptoms are the most common cause of heart failure hospitalizations that generate a staggering $40 billion spent on heart failure management in the nation annually.

"If you can identify a fire when it starts, you have a chance to contain it - if we can keep patients' LAP within the normal range, we can improve their quality of life and have a better chance of keeping them out of the hospital."

The LAPTOP-HP trail has a target enrollment of about 730 patients. Craig hopes to enroll as many as 20 patients at MUSC before the study ends in 2013.

The LAP monitoring system includes the following components:
-A small, pacemaker-sized, stand-alone implantable LAP monitoring device, or a cardiac rhythm management device (CRT/ICD) with LAP monitoring capabilities
-A lead, or thin wire, from the device to the heart, with an LAP sensor
- Patient Advisor Module (PAM), a portable, wireless, handheld device that is used by the patient to check LAP status and which directs the patient to take specific medicines or make lifestyle adjustments based on the LAP measurement
- DynamicRX, a software system that provides patients twice-daily feedback on their therapies, based on physician-prescribed treatment parameters.

Friday, June 1, 2012

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