Status:
WITHDRAWN
If Channel Blockade With Ivabradine in Patients With Diastolic Heart Failure
Lead Sponsor:
St Vincent's University Hospital, Ireland
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate whether the medicine ivabradine, a novel drug which slows the heart rate has a favourable effect on patients with diastolic heart failure. Ivabradine is a ...
Detailed Description
Background: Almost half of all patients with heart failure (HF) have preserved systolic function (PSHF) or heart failure with normal ejection fraction (HFNEF). Some of these have valvular abnormaliti...
Eligibility Criteria
Inclusion
- All patients must have a clinical diagnosis of diastolic heart failure as defined by all 3 of the following criteria:
- Presence of clinical heart failure for greater than or equal to 3 months before the screening visit. At the time of enrollment they should be in NYHA functional class I-III heart failure
- Left ventricular ejection fraction (LVEF) of greater than or equal to 50% (by echo or ventriculography) within 3 months of screening and LVEF still greater than or equal to 50% on day of enrollment
- BNP (b-type natruretic peptide) greater than or equal to 200 pg/ml at time of heart failure diagnosis
- Patients must be euvolaemic on clinical examination and have been clinically stable for at least 4 weeks with no medication changes
- Systolic blood pressure less than or equal to 150 mmHg but \> 85 mmHg and diastolic blood pressure less than or equal to 95 mmHg for 4 weeks prior to and at the time of enrollment
- Able to walk at least 50 meters at time of enrollment
Exclusion
- Aged \< 18 or \> 85
- Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant
- Any planned revascularisation i.e. CABG or stenting or performed within last 90 days
- Any myocardial infarct within last 90 days
- Significant chronic obstructive airways disease in the opinion of the investigator
- Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
- Inability to sign informed consent
- Atrial fibrillation
- Heart transplant recipient
- Currently implanted left ventricular assist device
- Stroke in past 90 days
- Gastrointestinal disorder that could interfere with study drug absorption
- Known intolerance to ivabradine
- Current participation (including prior 30 days) in any other therapeutic trial
- Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00757055
Start Date
December 1 2012
End Date
January 1 2014
Last Update
November 25 2014
Active Locations (1)
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1
Heart Failure Unit, St Michaels Hospital
Dublin, Ireland