Systolic heart failure
Conditions
Interventions
A prospective randomized controlled trial that will allocate 70 patients to treatment with renal nerve ablation (using the Boston Scientific Vessix system) or optimal medical therapy alone (1:1).
Sponsors
Erasmus Medical Center
Rotterdam, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ¡Ý18 and ¡Ü75 years; 2. Systolic ejection fraction (established on echo) 30ml/min/1.73m2 or more; 6. Written informed consent; 7. The patient agrees to the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. Renal artery abnormalities; 3. Acute heart failure; 4. An office based systolic blood pressure of <110mmHg; 5. Recent (<3months) stroke or myocardial infarction; 6. Hypertrophic obstructive cardiomyopathy, constrictive pericarditis; 7. The patient has other medical illnesses (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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint Change in iodine 123 meta-iodobenzylguanidine (123I-mIBG) heart to mediastinum ratio at 6 months. Primary safety endpoint The occurrence of a combined endpoint of cardiovascular death, rehospitalization for heart failure, and acute kidney injury at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 • Change in 123 meta-iodobenzylguanidine (123I-mIBG) washout at 6 months • 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) | — |
Contacts
Public ContactJoost Daemen
P.O. Box 2040, 3000 CA Rotterdam, The Netherlands, internal postal address Ba-593
Outcome results
None listed