To assess the safety and efficacy of endovascular renal nerve ablation in patients with systolic heart failure.
ID
Bron
Verkorte titel
Aandoening
Systolic heart failure
Ondersteuning
Rotterdam, the Netherlands
- Thoraxfoundation
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary efficacy endpoint
Change in iodine 123 meta-iodobenzylguanidine (123I-mIBG) heart to mediastinum ratio at 6 months.
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Primary safety endpoint<br>
The occurrence of a combined endpoint of cardiovascular death, rehospitalization for heart failure, and acute kidney injury at 6 months.
Doel van het onderzoek
To assess the safety and efficacy of endovascular renal nerve ablation in patients with systolic heart failure.
Onderzoeksopzet
Primary efficacy and safety endpoint: at 6 months
Secondary safety endpoints (at 1, 3 and 6 months and yearly up to 5 years):
Onderzoeksproduct en/of interventie
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).
Publiek
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
Wetenschappelijk
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ¡Ý18 and ¡Ü75 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5180 |
| NTR-old | NTR5328 |
| CCMO | NL |