Diastolic heart failure
Conditions
Interventions
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:
Sponsors
south manchester university hospital nhs trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) Clinical evidence of pulmonary or peripheral oedema. 2) History of asthma or significant reversible chronic obstructive airways disease (reversibility in FEV1 of > 15%) 3) Hypotension (BP < 100/60) 4) Significant bradycardia (heart rate < 55 bpm), 2nd or 3rd degree AV block. 5) History of intolerance to beta-blocker treatment. 6) Diagnosis of constrictive pericarditis. 7) Presence of severe peripheral vascular disease. 10) Myocardial infarction within 3 months prior to enrolment. 11) Female patients, who are pregnant, breast feeding or planning pregnancy during the course of the study. 12) Use of any investigational drug within 2 weeks of enrolment into the study. 13) Recent changes (less than 2 weeks) in cardiac medications other than that instituted by the investigators. 14) Significant co. morbid disease with a limited prognosis such that likely period of survival from the co morbidity is less than a year. 15) Clinically significant abnormality identified on screening history, physical examination, laboratory tests, ECG or Echocardiogram, which in the judgment of the investigator would preclude safe completion of the study. 16) An indication of beta-blocker treatment arises during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of beta-blocker treatment in diastolic heart failure.;Secondary Objective: ;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. | — |
Countries
United Kingdom
Outcome results
None listed