Renal Denervation in Heart Failure With Preserved Ejection Fraction

Cardiac Failure Clinical Trial

— RDT-PEF  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840059
• Other study ID #: 2012HS001B
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: September 14, 2015
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure

Intervention

Device:
• Renal sympathetic denervation
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

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Sobotka PA, Krum H, Böhm 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Symptoms	Minnesota Living with Heart Failure Questionnaire	12 months	No
Primary	Change in Exercise Function	Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing	12 months	No
Primary	Change in Heart Failure Biomarker	BNP (Natriuretic peptide)	12 months	No
Primary	Change in LV (Left Ventricle) filling pressure	E/E' on echocardiography	12 months	No
Primary	Change in LV remodelling	LV mass index	12 months	No
Primary	Change in Left atrial (LA) size	LA volume index	12 months	No
Secondary	Change in Autonomic function	Heart rate variability	3 and 12 months	No
Secondary	Change in Renal function	Urea and Creatinine	3 and 12 months	Yes
Secondary	Change in Vascular function	Aorta MRI (Magnetic Resonance Imaging)	3 and 12 months	No
Secondary	Change in Autonomic function	mIBG radiotracer assessment	3 and 12 months	No
Secondary	Change in neurohormones	Neurohormones	3 and 12 months	No
Secondary	Change in renal blood flow	Renal MRI	3 and 12 months	Yes
Secondary	Change in Blood pressure	ABPM (Ambulatory Blood Pressure Monitoring)	3 and 12 months	No
Secondary	Change in Endothelial function	EndoPat	3 and 12 months	No