Ileana L. Piña, MD


November 09, 2010

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Hello, this is Ileana Piña, Professor of Medicine at Case Western University in Cleveland. This is a brief video blog to get you excited about the American Heart Association's National Sessions that will be starting next week in Chicago.

We have changed much of the organization of the national meeting into cores and I'm particularly talking about Core 5, which is the heart failure core. There are many interesting late-breaking trials that will be presented at this meeting, but I want to focus on 3 that are very important to the heart failure world for all providers who take care of patients who have heart failure, and ultimately, for the patients themselves.

The 3 late-breaking trials consist of (1) a study of NT-proBNP (N-terminal pro-B-type natriuretic peptide, which has been discussed on this Website before); (2) the ASCEND (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial that has to do with nesiritide; and (3) a trial of an aldosterone blocker (eplerenone) -- a study that was performed primarily in Europe.

I will start with the first trial about NT-proBNP. This is called PROTECT (Pro-BNP Outpatient Tailored Chronic Heart Failure Therapy), a single-center study conducted in Boston by Dr. Januzzi. Jim Januzzi has had a longstanding interest in BNP use in patients who have heart failure, so the question here is, "If we get the BNP values, what to do with them?" Should we augment background therapy? Should we augment only diuretics? If, in fact we change the BNP values, will this make any difference to the patient outcome?

The study was small (approximately 150 patients) and the patients were randomized either to clinicians who knew the BNP levels or to another group of clinicians who did not know the BNP levels, but dealt with the patients clinically, and made attempts to optimize medical therapy. In this blog, we have often discussed the importance of optimization of medical therapy.

The study is very exciting; it was accepted as a late-breaking trial, so we can't discuss the results here, but I want you to be on the lookout for it because if the results are in fact encouraging, we hope that the National Institutes of Health will look at this as a very strong suggestion that we do need a large randomized clinical trial in a larger population that will examine what can happen to outcomes if we deal with these levels of BNP or proBNP.

The second trial is ASCEND, which has been one of the most rapidly enrolling trials in the history of heart failure clinical trials. It enrolled 7000 patients internationally. The study was designed to answer concerns that were raised about nesiritide and worsening of renal dysfunction, and perhaps, worsening of outcomes.

The drug was approved for intravenous use to relieve dyspnea in patients who came in with decompensated heart failure. Subsequent papers showed worsening renal function in subsets of the population and there were inferences about worsening outcomes, so this is a very important trial that randomized patients to either nesiritide vs placebo at the time of admission. Look out for this paper too; this will be important.

The third trial has to do with the earlier use of an aldosterone-blocking agent, in this case eplerenone. We have known from RALES (Randomized Aldactone Evaluation Study) that the use of spironolactone in patients who have class IV failure and have been in the hospital for heart failure within the past 6 months, that spironolactone in that case, in the RALES trial, markedly reduced mortality and thus the use of spironolactone in this very sick group of patients made it into the guidelines. However, we did not have information about the middle-of- the-road patients who are primarily class II and III, who may or may not have had an admission to the hospital and what would happen to outcomes with the addition of eplerenone.

That is the third trial that I want you to watch out for. Please follow us on Twitter® -- the American Heart Association has Twitter® to follow along with the late-breaking trials. They will be presented early in the week. The meeting begins officially on Sunday, and will end on Wednesday. For those of you who are able come to the American Heart Association meeting, it's bound to be exciting with lots of new information that will help you take better care of your patients. With that, I leave you; I hope to see you there. Thank you for joining me today. Good day.


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