None listed
Conditions
Brief summary
We will test a new approach to a form of heart failure (HF) with no current treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These “stiff” hearts pump strongly but fill inefficiently resulting in poor exercise capacity and high death rates. Treatments that help when heart pumping action is poor are of no benefit in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the kidneys (“renal denervation”; RDN) has been able to reduce BP in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in HF. We will compare effects of RDN and standard medical treatment on heart function, exercise capacity and quality of life in 144 patients with HFPEF.
Interventions
Renal Denervation (RDN) is a simple catheter procedure removing excess nerve signals to and from the kidneys. The renal denervation system consists of a small steerable treatment catheter and an automatically-controlled treatment delivery generator. The treatment does not require open surgery.
A guiding catheter is inserted through a tiny incision in the groin into the femoral artery to direct the treatment catheter to the renal arteries. The treatment catheter delivers high-frequency radio wav
Renal Denervation (RDN) is a simple catheter procedure removing excess nerve signals to and from the kidneys. The renal denervation system consists of a small steerable treatment catheter and an automatically-controlled treatment delivery generator. The treatment does not require open surgery. A guiding catheter is inserted through a tiny incision in the groin into the femoral artery to direct the treatment catheter to the renal arteries. The treatment catheter delivers high-frequency radio waves, called RF waves, to 4–6 locations within each of the two renal arteries. The energy delivered is about 8 watts. This energy delivery aims to disrupt the nerves and lower blood pressure over a period of months. The procedure takes 40 -60 minutes. RDN has been able to reduce Blood Pressure (BP) in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in Heart Failure (HF).
Sponsors
Christchurch Heart Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed