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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Experimental | Renal denervation using the Medtronic Symplicity catheter. |
|
| Control | No Intervention | HF-PEF patients who will serve as control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathetic denervation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms | Minnesota Living with Heart Failure Questionnaire | 12 months |
| Change in Exercise Function | Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing | 12 months |
| Change in Heart Failure Biomarker | BNP (Natriuretic peptide) | 12 months |
| Change in LV (Left Ventricle) filling pressure | E/E' on echocardiography | 12 months |
| Change in LV remodelling | LV mass index | 12 months |
| Change in Left atrial (LA) size | LA volume index | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Autonomic function | Heart rate variability | 3 and 12 months |
| Change in Renal function | Urea and Creatinine | 3 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo di Mario | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22392370 | Background | Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| Change in Vascular function | Aorta MRI (Magnetic Resonance Imaging) | 3 and 12 months |
| Change in Autonomic function | mIBG radiotracer assessment | 3 and 12 months |
| Change in neurohormones | Neurohormones | 3 and 12 months |
| Change in renal blood flow | Renal MRI | 3 and 12 months |
| Change in Blood pressure | ABPM (Ambulatory Blood Pressure Monitoring) | 3 and 12 months |
| Change in Endothelial function | EndoPat | 3 and 12 months |