A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiac Failure
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Symptoms
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).
Detailed Description
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)
Exclusion Criteria
- •Previously documented EF\<40%
- •Hypertrophic, restrictive, dilated cardiomyopathy
- •Significant valvular heart disease
- •Unfavourable renal artery anatomy for renal denervation
- •Contraindication to MRI
- •Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months
Outcomes
Primary Outcomes
Change in Symptoms
Time Frame: 12 months
Minnesota Living with Heart Failure Questionnaire
Change in LV remodelling
Time Frame: 12 months
LV mass index
Change in Left atrial (LA) size
Time Frame: 12 months
LA volume index
Change in Exercise Function
Time Frame: 12 months
Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing
Change in Heart Failure Biomarker
Time Frame: 12 months
BNP (Natriuretic peptide)
Change in LV (Left Ventricle) filling pressure
Time Frame: 12 months
E/E' on echocardiography
Secondary Outcomes
- Change in Blood pressure(3 and 12 months)
- Change in Renal function(3 and 12 months)
- Change in neurohormones(3 and 12 months)
- Change in Autonomic function(3 and 12 months)
- Change in Vascular function(3 and 12 months)
- Change in renal blood flow(3 and 12 months)
- Change in Endothelial function(3 and 12 months)