Endovascular Renal Sympathetic Denervation using the Boston Scientific Vessix V2 renal denervation system to Improve Heart Failure

Endovascular Renal Sympathetic Denervation using the Boston Scientific Vessix V2 renal denervation system to Improve Heart Failure - IMPROVE-HF-I

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40689

Enrollment

Registered

2014-04-24

Start date

2014-09-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Systolic ejection fraction (established on echo)

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Renal artery abnormalities; 3. Acute heart failure; 4. A systolic office based blood pressure of

Design outcomes

Primary

Measure	Time frame
Difference in iodine 123 meta-iobenzylguanidine (123I-mIBG) late heart to mediastinum ratio at 6 months.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)