Contact: Amanda Jekowsky, ajekowsk@acc.org, 202-731-3069

OUTCOMES IN CHRONIC HEART FAILURE NOT IMPROVED BY MONITORING KEY BIOMARKER
Danish Heart Clinics Continue Search for New Ways to Help High-risk Patients

New Orleans, LA – Blood levels of NT-proBNP – a protein secreted when the heart does not pump efficiently – rise as heart failure advances. A Danish study found no clinical benefit from using this biomarker to identify and monitor high-risk patients with chronic heart failure, according to research from the NorthStar study presented today at the American College of Cardiology’s 60th Annual Scientific Session. ACC.11 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further advances in cardiovascular medicine.

The study explored whether outcomes could be improved for patients classified as high risk because of high NT-proBNP levels by tracking that biomarker in specialized heart failure clinics (HFCs), where patients already receive optimal therapy according to European guidelines and are not discharged until they are clinically stable.

A secondary interest was to compare outcomes for patients treated by HFCs vs. general practitioners (GPs). Nearly half (18) of the 40 HFCs in Denmark’s national health care system participated in the study, and nearly all Danes (98 percent) have a personal GP.
“HFCs do not currently stratify patients by risk because the Danish Society of Cardiology has a policy that all patients with heart failure should go to an HFC when it is diagnosed,” said Morten Schou, M.D., Ph.D., cardiology fellow at Hillerod University Hospital, Hillerod, Denmark, and the study’s principal investigator. “We want to continue to treat patients who remain symptomatic, but the question is whether patients who are considered stable should stay in the HFC pool, go back to hospital or to GP care.”

A total of 1,120 clinically stable patients were randomly assigned to five groups according to their risk status, as determined by NT-proBNP levels: low-risk (<1000 pg/ml) or high-risk (>1000 pg/ml). Low-risk patients were managed by a GP (257 patients) or an HFC (253 patients). High-risk patients were assigned to a GP (203 patients), an HFC for standard follow-up (208 patients) or an HFC for biomarker monitoring (199 patients). If NT-proBNP levels rose more than 30 percent in the monitoring group, those high-risk patients also received intensive evaluation guided by a checklist to find and treat the cause. All HFC patients visited a clinic every one to three months.

The primary endpoints were death and a composite of hospitalization for a cardiovascular event and death, and endpoints were blinded to treatment assignment. After a median follow-up of 2.8 years, the data were neutral for primary and secondary endpoints, which included heart failure, admission to a hospital and number of days hospitalized. Outcomes were similar for GP and HFC patients regardless of risk status. The low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the HFC group. For the high-risk patients, deaths and composite events by group were: GP, 37 and 78; HFC, 38 and 85; and HFC with monitoring, 46 and 92. The study found no increase in hospital admissions or hypotension in the GP or in the monitoring arm.

“We found that if you do your initial job carefully in the HFC to optimize patients, the concept of stratifying by risk and following the patient in the HFC fails, and that was a bit of a surprise for us,” Schou said. “We have to find new concepts to improve outcomes for patients on optimal therapy who have high NT-proBNP levels.”

Dr. Schou will be available to the media on Tuesday, April 5, at 12:30 p.m. CDT, in Room 338/339.
Dr. Schou will present the study, “NT-proBNP Stratified Long-term Follow-up in Outpatient Heart Failure Clinics: A Prospective Randomized Multicenter Trial in the Danish Heart Failure Clinics Network,” on Tuesday, April 5, at 10:45 a.m. CDT, in the Joint Main Tent: La Nouvelle.

The American College of Cardiology (www.cardiosource.org) represents the majority of board-certified cardiovascular care professionals through education, research, promotion, development and application of standards and guidelines – and to influence health care policy. ACC.11 is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
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