Cardiac Failure
Conditions
Keywords
Cardiac Failure, Autonomic Denervation
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.
Interventions
A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* EF\>40% * NHYA 2-3 * 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 * eGFR\<45 * Contraindication to MRI * Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms | 12 months | Minnesota Living with Heart Failure Questionnaire |
| Change in Exercise Function | 12 months | Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing |
| Change in Heart Failure Biomarker | 12 months | BNP (Natriuretic peptide) |
| Change in LV (Left Ventricle) filling pressure | 12 months | E/E' on echocardiography |
| Change in LV remodelling | 12 months | LV mass index |
| Change in Left atrial (LA) size | 12 months | LA volume index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Autonomic function | 3 and 12 months | Heart rate variability |
| Change in Endothelial function | 3 and 12 months | EndoPat |
| Change in Renal function | 3 and 12 months | Urea and Creatinine |
| Change in Vascular function | 3 and 12 months | Aorta MRI (Magnetic Resonance Imaging) |
| Change in neurohormones | 3 and 12 months | Neurohormones |
| Change in renal blood flow | 3 and 12 months | Renal MRI |
| Change in Blood pressure | 3 and 12 months | ABPM (Ambulatory Blood Pressure Monitoring) |
Countries
United Kingdom
Outcome results
None listed