ovel Interventions in Heart Failure with Preserved Ejection Fraction using ivabradine
Phase 4
- Conditions
- Heart Failure with Preserved Ejection FractionCardiovascular - Other cardiovascular diseases
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Age greater than or equal to 18 years
HF-PEF (LVEF greater than or equal to 50% within 6m of randomisation)
NYHA II-III
Diastolic dysfunction on echo
E/A equal to 1, E/E’ equal to or greater than 15, deceleration time less than or equal to 140ms
Heart rate over 70/min
Stable disease, confirmed by no hospital admissions or HF medication changes within 3m prior to randomisation
Informed consent
No other causes for exertional dyspnoea
Exclusion Criteria
Atrial Fibrillation
Contraindications to MRI
Significant valvular or coronary disease as primary cause of HF
Hypertrophic cardiomyopathy, cardiac amyloidosis, sarcoidosis
GFR equal to or greater than 45 ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in 6 minute walk test[Baseline, 8 and 18 weeks after randomistaion];Peak VO2 as assessed by cardio-pulmonary exercise testing. The Vo2 is calculated using the difference between the heart rate at rest and at peak exercise. The heart rate blood pressure and concentaration of inspired oxygen will be monitored regularlr by monitors.[Baseline, 8 and 18 weeks after randomistaion]
- Secondary Outcome Measures
Name Time Method RV volume as assessed on cardiac magnetic resonance imaging[Baseline, 8 and 18 weeks after randomistaion];Diastolic parametres of E/E', E/A ratio on echocardiogram[Baseline, 8 and 18 weeks after randomistaion]