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Renal denervation to improve heart failure


- candidate number22499
- NTR NumberNTR5328
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2015
- Secondary IDsNL 47953.078.14
- Public TitleRenal denervation to improve heart failure
- Scientific TitleEndovascular Renal Sympathetic Denervation using the Boston Scientific Vessix V2 renal denervation system to Improve Heart Failure
- ACRONYMIMPROVE-HF-I Study
- hypothesisTo assess the safety and efficacy of endovascular renal nerve ablation in patients with systolic heart failure.
- Healt Condition(s) or Problem(s) studiedHeart failure
- Inclusion criteria1. Age 18 and 75 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-jul-2016
- Target number of participants70
- InterventionsA 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).
- Primary outcomePrimary 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 outcomeSecondary 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)
- TimepointsPrimary efficacy and safety endpoint: at 6 months

Secondary safety endpoints (at 1, 3 and 6 months and yearly up to 5 years):

- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Joost Daemen
- CONTACT for SCIENTIFIC QUERIESMD, PhD Joost Daemen
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Boston Scientific, Thoraxfoundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-jul-2015 - 24-aug-2015


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