Dose finding study in chronic congestive heart failure patients. Results of a short- and long-term study

A multi-center open trial was carried out with 103 patients with chronic congestive heart failure (CHF) of diverse etiologies with oedemas, 25 with hepatomegalia, placed in classes II or III of NYHA functional capacity, with increasing doses of 30, 60 and 90 mg of muzolimine qd to ascertain (1) the effective dose for the elimination of oedemas and hepatomegalia and (2) whether such a dose keeps its efficacy throughout a long administration period. After a wash-out period of 3-7 days, heart rate (HR), systolic (SBP) and diastolic blood pressure (DBP) in supine and standing positions, body weight (BW) and 24 hour diuresis were controlled and laboratory tests were performed. Muzolimine was administered and an assessment of the therapeutic effect was carried out every week. When the clinical results were ineffective, the dose was increased weekly up to 90 mg. When the results were partial, the same dose was given for another week and when it was effective the search for the dose was concluded. Out of the 103 patients, 67 needed only 30 mg of muzolimine for an effective elimination of oedemas and hepatomegalia, 32 needed 60 mg and only 4 had to have the dose increased to 90 mg to obtain efficacy. The SBP and DBP diminished by 6.3% and 7.2% respectively, and HR was reduced, though not significantly. BW diminished an average of 2.4 Kg and the diuresis increased significantly from a mean value of 1.043 ml/24 h to 1.714 ml/24 h. Sixty-two patients with effective results agreed to undergo chronic treatment for 24 weeks and be controlled every 2 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)