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It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation + medical therapy | Experimental | Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure |
|
| Medical therapy | No Intervention | Standard optimized medical therapy for diastolic heart failure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation + medical therapy | Procedure | Renal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change from baseline E/E' on echocardiography at 12 months | 12 months after treatment | |
| Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline E/E' on echocardiography at 6 months | 6 months | |
| Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro A Lemos, MD PhD | Heart Institute - InCor. University of Sao Paulo Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute - InCor. University of Sao Paulo Medical School | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Change in any echocardiographic diastolic parameter between baseline and 12 months |
| 12 months |
| Change in 6 min walking distance between baseline and 12 months | 12 months |
| Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months | 12 months |
| Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months | 12 months |
| Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months | 12 months |
| Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months | 12 months |
| Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months | 12 months |