Clinical trial NCT01840059: Renal Denervation in Heart Failure With Preserved Ejection Fraction
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Failure
Keywords: Cardiac Failure
Autonomic Denervation
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptoms
timeFrame: 12 months
measure: Change in Exercise Function
timeFrame: 12 months
measure: Change in Heart Failure Biomarker
timeFrame: 12 months
measure: Change in LV (Left Ventricle) filling pressure
timeFrame: 12 months
measure: Change in LV remodelling
timeFrame: 12 months
measure: Change in Left atrial (LA) size
timeFrame: 12 months
Secondary outcomes:
measure: Change in Autonomic function
timeFrame: 3 and 12 months
measure: Change in Renal function
timeFrame: 3 and 12 months
measure: Change in Vascular function
timeFrame: 3 and 12 months
measure: Change in Autonomic function
timeFrame: 3 and 12 months
measure: Change in neurohormones
timeFrame: 3 and 12 months
measure: Change in renal blood flow
timeFrame: 3 and 12 months
measure: Change in Blood pressure
timeFrame: 3 and 12 months
measure: Change in Endothelial function
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Carlo di Mario
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.