RESUMO
A randomized, prospective, open-ended study of 20 Pakistani patients with moderate-to-severe heart failure [NYHA class II and III] was carried out. Patients had to have global left ventricular [LV] dysfunction with ejection fraction [LVEF] <35%. The patients were randomized into two groups, C and E. Group C patients [N=9] were optimized on conventional therapy i.e. diuretic, digoxin and nitrates whereas group E patients [N=11] had enalapril added to this therapy and increased gradually. The subjects were followed for a period of 12 to 120 weeks with a mean of 58 weeks. Serial tests were done at 12 weekly intervals. These included echocardiography, exercise stress test, urea, creatinine, sodium and potassium. Showed a significant improvement in NYHA class in group E. 10 of the 11 patients in this group improved by one class while only 1 out of 9 patients improved by one class in group C. There was a highly significant [p< 0.001] increase in exercise time in group e from 417 sacs to 730 while there was an insignificant increase in group C. Hemodynamic measurements showed a significant fall in heart rate in group E from 90 bpm to 83 bpm [p=0.01] but an insignificant fall in group C from 94 bpm to 86 bpm. Systolic and diastolc blood pressure [BP] fell in both groups [121/81 vs 108/74 in group C and 117/77 vs 110/72 in group E] but only the fall in systolic BP in group E was significant [p=0.05]. Echocardiography showed significant improvement in left ventricular systolic [p=0.001] and diastolic [p< 0.05] dimensions and LVEF [p< 0.001] in group E while there was no significant change in group C. In addition, digoxin usage fell significantly in group C. Cough was more prevalent in group E, this did not reach significance levels. Other side effects were not significantly different between the two groups serial blood tests also did not show any significant difference. In conclusion, the addition of enalapril to conventional therapy in Pakistani patients of moderate-to-severe heart failure significantly improved NYHA class, exercise capacity, LV dimensions and LVEF. In addition, it also reduced the need for other anti-heart failure medications and was generally well tolerated