Compensated Heart Failure Clinical Trial
Official title:
Randomized, Open-Label, Blinded-Endpoint, Crossover, Single Dose Study to Compare the Pharmacodynamics of Torasemide-PR 10 mg,Torasemide-IR 10 mg and Furosemide-IR 40 mg, in Patients With Compensated Heart Failure (CHF).
This is a randomized, open-label, blinded-endpoint, crossover, single dose study to compare
the pharmacodynamics of Torasemide-PR 10 mg, Torasemide-IR10 mg and furosemide-IR 40 mg. 30
patients of both sexes with CHF with a maximum imbalance of 60:40% in either direction will
be included in the study. Patients with compensated heart failure, grade II or III as
defined by the European Society of Cardiology, with a duration of ≥ 3 months at the time of
inclusion documented in the patient's record or patients who previously required diuretic
therapy.
Principal variable will be the efficiency of sodium excretion that will be assessed as the
ratio between the average drug-induced natriuresis and the average drug recovered in urine
over 24 hours.
The difference between the efficiency of 24 hour sodium excretion following administration
of torasemide PR and furosemide will be formally tested by means of a Students t-test for
paired samples. The test will be two-sided at 5% significance level. Efficiency changes over
time will also be assessed, however will not be subject to formal statistical testing.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment