Japanese Diastolic Heart Failure Study

UMIN ID: C000000318

Registered date:01/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diastolic heart failure
• Date of first enrollment: 2004/05/01
• Target sample size: 800
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treatment without beta-blocker. Until the end of this study,
Treatment with beta- blocker Until the end of this study

Outcome(s)

• Primary Outcome: a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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 < 50 bpm Second or third degree heart block without permanent pacemaker in situ. Acute coronary syndrome Arrhythmogenic right ventricular cardiomyopathy Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction Serious cerebrovascular disease Acute myocardial infarction within the last 3 months Patients who require intravenous inotropes Cerebrovascular accident within the last 6 months Percutaneous coronary intervention or open heart surgery within the last 3 months On the waiting list for percutaneous coronary intervention or open heart surgery Serum creatinine > 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

Related Information

• Primary Sponsor: J-DHF Study group
• Source(s) of Monetary Support: the Research Grant for Cardiovascular Diseases (15C-2),Japan Heart Foundation