Data From Eight Drug Clinical Trials Presented at Heart Failure 2009

 

June 1, 2009

June 1, 2009 - Results and updates from eight studies were presented during a late-breaking trials session at Heart Failure 2009, May 30 – June 2 in Nice, France.

Professor John McMurray, president of the Heart Failure Association, described the trials’ objectives and main implications.

• A multicenter study of a new inotropic drug (which increases the contraction and pumping of the heart), CK-1827452, found that it increases systolic function in stable heart failure patients – and was well tolerated in a proof of concept study. CK-1827452 is a new drug in a class known as selective cardiac myosin activators. Bigger trials are now needed to assess safety and effect on clinically meaningful endpoints.

• PreRELAX-AHF is another proof of concept study with an interesting new vasodilator drug (relaxin), a hormone produced by the ovaries and placenta during pregnancy, which causes expansion of the cervix and uterus. Because relaxin also relaxes arteries and veins, it reduces the resistance to blood flow in these vessels - and hence the work the heart has to do to pump blood through them. Results of this trial are encouraging and showed that relaxin given for 48 hours produce rapid and sustained improvement in breathlessness and other heart failure symptoms, with a favorable impact on clinical outcomes at 60 days. Again, bigger trials are now needed to assess safety and effect on clinically meaningful endpoints.

• CHANCE (Congestive Heart failure: A multidisciplinary Non-pharmacological approach for Changing in rE-hospitalization and prognosis) is an important study from Russia looking at whether post-discharge nonpharmacological interventions by nurses and other health professionals could reduce the risk of hospital readmission. The study found that an approach of patient education and active follow-up (added to optimal medical care) decreased morbidity and mortality. This reinforces the findings of previous studies in other countries and suggests that organized multidisciplinary care is beneficial for patients with heart failure in a variety of healthcare systems.

• B-convinced is a multicenter French study designed to assess the effect of temporarily discontinuing beta-blockers in patients whose worsening heart failure leads to hospital admission. This reflects a frequent clinical dilemma, but results showed during acute heart failure beta-blocker therapy should not be withdrawn.

• CHAT (Chronic Heart failure Assistance by Telephone) is a study looking at whether telephone intervention (with advice about symptoms, treatment, etc.) might be helpful in reducing the risk of major heart failure events (hospital admissions/death) in patients living in rural areas, where organized, multidisciplinary care is not available. Results from this randomized trial performed in Australia suggest telephone support can significantly reduce mortality and hospitalization rate in a rural and remote cohort.

• CIBIS-ELD (Cardiac Insufficiency Bisoprolol Study in Elderly) was designed to assess and compare the dose of two proven beta-blockers in elderly patients with heart failure (the elderly are often “underdosed” and there is always debate about whether one drug might be better tolerated than another). This study showed that it is indeed hard to achieve the target dose in elder patients, and that there was no difference in tolerability between the two (bisoprolol and carvedilol).

* Ex-DHF is a study that looked at a neglected type of heart failure, diastolic HF (or HF with preserved ejection fraction). There are no proven treatments for this type of heart failure, and this study tested the value of exercise training. The results showed that this intervention improved exercise capacity, made patients feel better and, importantly, seemed to improve the abnormalities in the structure and function of the heart in these patients.

• SIGNAL-HF studied the very topical and important question of whether use of the biomarker NT-pro BNP as a guide to pharmacological treatment in primary care would lead to an improvement in patient outcomes. It didn’t – and this will be a controversial conclusion alongside a number of conflicting and unconvincing recent findings in this area.

The late-breaking trials session was held June 1. The Heart Failure Congress 2009 is organized by the European Society of Cardiology and Heart Failure Association of the ESC.

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