A Pilot study to assess the effects of beta-blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Trade Name: Cardicor Product Name: Bisoprolol Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Cardicor Product Name: Bisoprolol Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Cardicor Product Name: Bisoprolol Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Diastolic heart failure PRIMARY OUTCOME: Main Objective: To assess the effect of beta‐blocker treatment in diastolic heart failure. Primary end point(s): 1) The primary efficacy variable is the change from baseline in plasma BNP measurements; 2) The secondary efficacy variable is distance walked during 6‐minute walk test, a change from baseline serum CRP and interleukin 6 levels. ; ; Secondary Objective: INCLUSION CRITERIA: All patients must satisfy all of the following criteria to be entered into the study. 1) Evidence or history of clinical heart failure. 2) Ejection fraction of >45%. 3) Raised Plasma BNP levels. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 54e7fc4af8b31b048d36e4ffaf1130a73ce57e0c
First added on: Aug 21, 2024