The RALES study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with NYHA III or IV heart failure. This favourable effect was clearly independent from a diuretic effect. Antialdosterone drugs may be effective because they opposes the effects of aldosterone on sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor function and vascular compliance. Antialdosterone treatment may also antagonize the effect of aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a marker of cardiac fibrosis synthesis showed an independent negative correlation with survival and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in patients with mild heart failure assuming standard therapy.
The protocol is sponsored by and independent organization and partially supported by Therabel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
500
Presidio GM Lancisi
Ancona, Italy
Az Ospedaliera Giuseppe Moscati
Avellino, Italy
Presidio Ospedaliero Moscati
Aversa (CE), Italy
Ospedale Monsignor Angelo R di Miccoli
Barletta (BA), Italy
Ospedali Riuniti
Bergamo, Italy
Cardiologia Tiarini Corticella
Changes in echocardiographic left ventricular diastolic volume
Changes in left ventricular systolic volume
Changes in ejection fraction
Changes in NYHA class
cardiac mortality
hospitalization for cardiac causes
combination of cardiac mortality hospitalizations for cardiac causes
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Bologna, Italy
Ospedale Generale Provinciale
Bolzano, Italy
Az Osp G Brotzu - S Michele
Cagliari, Italy
Az Ospedaliera S Anna e S Sebastiano
Caserta, Italy
Ospedale San Raffaele G Giglio
Cefalù (PA), Italy
...and 35 more locations