A study of Renal Denervation for Heart Failure with Preserved Ejection Fraction to reduce left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI).

Christchurch Heart Institute0 sites20 target enrollmentMay 15, 2013

Overview

No summary available.

Registry

who.int

Start Date

May 15, 2013

End Date

December 31, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Christchurch Heart Institute

•\*Patients with HFPEF (based upon ESC diagnostic criteria)
•a. Symptoms and signs of heart failure; NYHA Class II or higher
•b. Left ventricular ejection fraction 50% or greater on echocardiography
•c. Echocardiographic evidence of left ventricular diastolic dysfunction (echo\-Doppler E/e’ \> 15 ) AND/OR plasma NTproBNP \> 220pg/ml.
•\*Episode of acute decompensation (ADHF) requiring hospital admission within the 12 months prior to recruitment
•\*Patients with and without background hypertension may be recruited. In the case of patients with background hypertension (ie history of fulfilling the diagnostic WHO criteria for hypertension: SBP \> 140 mmHg and/or DBP \> 90 mmHg) those with both controlled (\<140/90mmHg by 24 hour ambulatory BP) and inadequately controlled BP (on 3 anti\-hypertensive drugs including a diuretic) can be recruited.

•\*Known secondary cause of hypertension
•\*Renal artery stenosis \>30% or anatomy otherwise unsuitable for RDN.
•\* Heart failure with reduced LV ejection fraction (LVEF \< 50%).
•\*Estimated glomerular filtration rate (eGFR) of \< 30mL/min/1\.73m2 (MDRD calculation).
•\*Systolic blood pressure \< 105mmHg.
•\*Implanted pacemaker, prosthetic heart valve or other precluding cMR scanning.
•\*Medical condition adversely affecting safety and/or effectiveness of the participant (including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or uncontrolled atrial fibrillation).
•\*Pregnant, nursing or planning to be pregnant.