It is a highly anticipated clinical study funded by the public authorities (the KCE, the Federal Center for Health Care Expertise). It is presented for the first time at the annual European Congress of Cardiology in Barcelona, this Saturday, August 27. ADVOR is its name (Acetazolamide in Decompesated heart failure with Volume OveRload) is also published in the prestigious New England Journal of Medicine. It might significantly improve the lives of patients with heart failure.
A cheap old diuretic
This new treatment consists of administering to patients a combination of existing diuretic drugs which are very inexpensive and which are no longer under patent. This is acetazolamide: this very old drug is hardly used anymore, except to treat glaucoma (an eye disease) and mountain sickness.
The team of Professor Mullens, from the Oost-Limburg clinic in Genk, Limburg, led this study, involving 29 Belgian hospitals. It included 519 patients in two groups: half were treated with a conventional diuretic (called a loop diuretic) combined with a placebo, while the other half received a conventional diuretic combined with acetazolamide. Results: Patients who received the combination of the two diuretics had a 46% increased chance of having eliminated excess fluid accumulated in the tissues, due to their heart failure.
“This is really a very important step“, explains Professor Wilfried Mullens, cardiologist at the Ziekenhuis Oost-Limburg and professor at the University of Hasselt. “The drug we tested is very cheap because it is no longer under patent protection. It is safe, easy to administer and therefore very effective. The future is therefore to implement this. So that doctors all over the world follow this lead for the millions of people who every day in the world are confronted with this disease.“.
Léon Melotte, 81, is one of the patients enrolled in the group treated with acetazolamide: arrived at the hospital very out of breath and with swollen feet, he suffered from heart failure. The treatment allowed him to lose 4 kilos of fluid accumulated in the tissues. “Today I feel good“, he said. “I can’t believe what has changed. And I’m free once more.“The patient also changed his lifestyle and eating habits, opting for a salt-free diet.
When the pump fails
In heart failure, which affects more than 200,000 Belgians, the heart is no longer able to pump enough blood to the organs and tissues. The consequence is that fluid accumulates in particular in the lungs. In everyday language, it is sometimes said that the patient “has water in the lungs”. This buildup causes extreme shortness of breath, which often requires hospitalization. Fluid also accumulates in the legs, and the feet swell. The risk of premature death is high.
Until now, the classic treatment consisted of administering a certain type of diuretic called a “loop diuretic” by intravenous infusion. However, the effectiveness of this treatment left something to be desired, and the risk of re-hospitalization or death might reach 60% in the first months.
A small revolution
The study has the additional merit of having been mobilized and financed by the public authorities, and of having been carried out in a network, in consultation between different hospitals in the country, both in the North and in the South. The supervision was carried out by the Clinical Trial Unit of the Ziekenhuis Oost-Limburg in Genk, with the support of the Limburg Clinical Research Center (LRCR).
“It is very difficult to have companies finance such a study.“, explains Katrien Tartaglia, Head of Clinical Studies at Ziekenhuis Oost-Limburg. “Fortunately, there is the KCE which finances such projects every year. Pragmatic projects which do not interest the industry at all, because it is a product which is not patented. It is very cheap. We so we are very happy. Research is very important for patients, but also for us as a small control unit. That we can show what we can do and that even a very small hospital can carry out studies of this magnitude.”
How is this study revolutionary? It might make it possible, for the first time in decades, to improve the quality of life of very many patients suffering from heart failure.