Preliminary observations of chronic indoramin therapy in congestive heart failure.

Twenty-one patients with congestive heart failure (New York Heart Association functional class III) underwent a double-blind, parallel, placebo-controlled, randomized trial of indoramin (average dose of 50 mg every 12 h in 11 patients) versus placebo (n = 10). The study lasted 2 months and was initiated and terminated with the measurement of resting and exercise hemodynamics. Compared with baseline values, chronic administration of indoramin caused a mild reduction in resting mean systemic blood pressure (mean change of -10 mm Hg), and postdosing results included a drop in systemic and pulmonary vascular resistances and pulmonary capillary wedge pressure and a mild increase in stroke volume. Compared with baseline responses, chronic indoramin administration (postdosing) elicited a mild reduction in systemic and pulmonary vascular resistances and pulmonary capillary wedge pressure during submaximal exercise. At this dose, chronic indoramin administration did not alter hemodynamics at maximal exercise or exercise duration to maximal exercise. While certain individual patients experienced clinical improvement on chronic indoramin therapy, the overall clinical status (symptoms, signs, diuretic requirements) of the indoramin-treated group did not change significantly when compared with that of the placebo control group.

RCT Entities:   Population Interventions Outcomes