Primary objective: To assess the safety and efficacy of endovascular renal nerve ablation using the Boston Scientific Vessix V2 renal denervation system in patients with systolic heart failure
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in iodine 123 meta-iobenzylguanidine (123I-mIBG) late heart to
mediastinum ratio at 6 months.
Secondary outcome
Primary safety endpoint
The occurrence of a combined endpoint of cardiovascular death,
rehospitalization for heart failure, and acute kidney injury at 6 months.
Other study parameters (if applicable, APPENDIX IV for definitions)
Secondary safety endpoints (at 1, 3 and 6 months and yearly up to 5 years):
• Major access site bleeding
• Individual parameters of the combined endpoint
• Change in renal function (eGFR, Cystatine C)
• Development of end stage renal failure
• Newly acquired renal artery stenosis and/or repeat renal artery intervention.
Secondary efficacy endpoints (at 1, 3 and 6 months and yearly up to 5 years):
• NYHA class baseline and follow-up
• Body weight reduction
• 6 minute walk test
• Change in diuretic dosage
• Difference in 24-hour urine sodium excretion
• Quality of life and overall physical and mental function (using RAND 36-
item health survey [RAND-36] and the Kansas City Cardiomyopathy questionnaire).
• Change in heart failure and diabetic medication
• Echocardiographic endpoints (ejection fraction, wall thickness, dimensions,
diastolic function, pulse wave velocity) (at baseline, 6 months and yearly up
to 5y)
• Blood and urine analyses (change in NT-proBNP and catecholamine levels, renal
function, liver function, blood count, cholesterol levels, glycemic control)
(at baseline, 3 months, 6 months and yearly up to 5y)
Background summary
Chronic heart failure ìs a global and growing health problem. Despite gradual
improvements in medical and device therapy, patients remain symptomatic and the
prognosis remains poor. Sympathetic overactivity has been documented in heart
failure with the severity of overactivity directly correlated to NYHA heart
failure class.
Endovascular renal nerve ablation has been introduced as a promising new
treatment modality to decrease sympathetic activity. Recently two small pilot
studies demonstrated the potential benefit of renal nerve ablation in systolic
heart failure. Currently no prospective randomized data is available on the
safety and efficacy of renal denervation in improving signs and symptoms of
heart failure.
Study objective
Primary objective: To assess the safety and efficacy of endovascular renal
nerve ablation using the Boston Scientific Vessix V2 renal denervation system
in patients with systolic heart failure
Study design
A prospective randomized controlled trial that will allocate 70 patients to
treatment with renal nerve ablation or optimal medical therapy alone (1:1).
Patients will be followed for 5 years and will be assessed at 1, 3, 6 and 12
months, and yearly up to 5y.
Intervention
The renal sympathetic denervation procedure will be started with gaining
femoral artery access, either left of right, using a standard endovascular
Seldinger technique to canulate the femoral artery. Placed percutaneously, the
Vessix renal denervation catheter will be advanced into the renal artery.
Radiofrequency ablation will be applied by using an automated programmed
algorhythm.
Study burden and risks
Patients will undergo thorough pre-procedure assessment and imaging assessment
(both MRI ultrasound) prior to selection and inclusion into the study. The
procedure is initiated by puncture of the femoral artery with its inherent
risks including bleeding, aneurysm formation, dissection, thrombosis and
perforation. However, these risks are not different from each comparable form
of angiography in which the groin is punctured and the access procedure is
known for its low and acceptable complication risk. An additional potential
procedure risk is caused by the radiofrequency ablation of the renal artery
with focal damage of the endothelium on the coagulation spots. However, study
data thus far do not show any signs of arterial damage due to the ablation
procedure.
Based on previous studies using the Simplicity renal denervation system in
approximately 350 patient, the following complications were recorded:
- damage to the blood vessels of the kidney in approximately 1% of the patients
- blood clots leading to heart attach or stroke in approximately 1-2%
- extended hospital stay in 1-2%
- pseudoaneurysm of the femoral artery in approximately 1-2% of the patients
- (temporarily) low blood pressure in 1-2% of the patients
- urinary tract infection in 1-2% of the patients
- renal artery stening in 1-2% of the patients
- arrhythmias during the procedure in 1-2%
In the recently presented interim data of the Vessix REDUCE-HTN trial, no
patient experienced prespecified acute safety events (n=146). A low rate of
procedure-related adverse events was noted (5.5%; including hematoma (1),
bilateral flank pain (1), vomiting (1), access site infection (2),
pseudoaneurysm at access site (1), femoral artery thrombus (1), renal artery
stenosis requiring treatment (1)).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18 years;
2. Systolic ejection fraction (established on echo) <35%;
3. NYHA Class II, III or IV heart failure despite optimal heart failure therapy;
4. Renal arteries suitable for the proposed treatment;
5. A glomerular filtration rate of 30ml/min/1.73m2 or more;
6. Written informed consent;
7. The patient agrees to the follow-up.
Exclusion criteria
1. Pregnancy;
2. Renal artery abnormalities;
3. Acute heart failure;
4. A systolic office based blood pressure of <110mmHg systolic;
5. Recent (<3months) stroke or myocardial infarction
6. Hypertrophic obstructive cardiomyopathy, constrictive pericarditis
7. The patient has other medical illness (i.e., cancer) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year);
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47953.078.14 |