No registrations found.
ID
Source
Brief title
Health condition
Systolic heart failure
Sponsors and support
Rotterdam, the Netherlands
- Thoraxfoundation
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Study objective
To assess the safety and efficacy of endovascular renal nerve ablation in patients with systolic heart failure.
Study design
Primary efficacy and safety endpoint: at 6 months
Secondary safety endpoints (at 1, 3 and 6 months and yearly up to 5 years):
Intervention
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).
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
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
Inclusion criteria
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.
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
Recruitment
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 |
|---|---|
| NTR-new | NL5180 |
| NTR-old | NTR5328 |
| CCMO | NL |