A trial to test reduction in renal nerve activity as a possible treatment for heart failure.

Phase 3

Completed

• Conditions: Heart Failure with Preserved Ejection Fraction; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000546752
• Lead Sponsor: Christchurch Heart Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Study Completion: 2017-12-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

*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.

Exclusion Criteria

*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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI) in Heart Failure with Preserved Ejection Fraction (HFPEF). [6 months]