Diastolic heart failure
Conditions
Interventions
Treatment without beta-blocker. Until the end of this study,
Treatment with beta- blocker Until the end of this study
Sponsors
J-DHF Study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Clinical diagnosis of heart failure based on a slight modification the Framingham criteria as previously described1 within 12 months before the entry. 2, Documentation of LV ejection fraction > 40% when diagnosed as heart failure 3, No change in baseline therapy and symptoms of heart failure within a month
Exclusion criteria
Exclusion criteria: Current symptomatic hypotension Hypertension that has not been controlled to the satisfaction of the investigator by drugs other than beta-blocker Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy) or mitral valve stenosis Important aortic or mitral regurgitation in the investigators opinion Heart rate 3.0 mg/dl or creatinine clearance with 30 ml/min or less Known bilateral renal artery stenosis Serum potassium > 5.5 mEq/l Serious liver disease Prescription of beta-blocker within a month, or a history of a life-threatening adverse event induced by beta-blocker Any change in cardiovascular drug therapy within a month prior to randomization History of chronic obstructive pulmonary disease or restrictive lung disease Diabetes mellitus that has not been controlled to the satisfaction of the investigator History of any life-threatening noncardiac disease (eg, cancer) within 5 years Other diseases likely to cause death or serious disability within a year Patients unable to walk without personal aid Arteriosclerosis obliterans with Fontaine grade II or more. Severe anemia (hemoglobin with 6.0 g/dl or less) Uncontrolled thyroid dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| all cause mortality; worsening of the symptoms (that is defined by either a decrease by 1 Mets or over in the SAS questionnaire score or an increase by I class or over in the NYHA functional class for at least 3 months as compared with the baseline); an increase in brain natriuretic peptide (BNP) by 30% or over of the value at the randomization in patients with BNP of 200 pg/ml or over at the randomization; unplanned admission to hospital for congestive heart failure, or a need for modification of the treatment for heart failure (changes in oral medicine for at least one month or addition of intravenous inotropes for at least 4 hours) | — |
Countries
Japan
Contacts
Public ContactKazuhiro Yamamoto
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed