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This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes in mean 24-hour ambulatory diastolic blood pressure over a 6-month follow-up period. The study is expected to provide evidence for the use of RDN as a treatment for IDH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation Group | Experimental |
| |
| Sham Control Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Procedure | Renal denervation (RDN) was performed using radiofrequency ablation in the cardiac catheterization laboratory equipped with a digital subtraction angiography (DSA) system. Under intravenous anesthesia, femoral artery access was obtained and a renal denervation sheath was advanced. An ablation catheter was then introduced to both renal arteries, and ablations were applied across four quadrants to achieve circumferential denervation. Throughout the procedure, vital signs were continuously monitored, and vasodilators or anticholinergics (e.g., nitroglycerin, atropine) were prepared to prevent vascular spasm or related complications. After completion, the femoral access site was closed and compressed, and patients were returned to the ward following stabilization of vital signs. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up | Hypertension control without antihypertensive medication was defined as the absence of two consecutive adjudications by the Clinical Event Committee (CEC) indicating a need for oral antihypertensive therapy during the follow-up period. The CEC performed 7 adjudications throughout the study based on office blood pressure measurements obtained at biweekly visits. The CEC was blinded to treatment allocation. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhang | Contact | 18917686332 | yizshcn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Renal Angiography | Procedure | Renal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN. |
|
| 6 months after intervention |
| Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up | 6 months after intervention |
| Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up | 3/6/12 months after intervention |
| Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up | 3/612 months after intervention |
| The incidence of procedure-related adverse events and complications at 6-month follow-up | Procedure-related adverse events and complications include renal artery stenosis, major bleeding, non-stroke thromboembolic events, renal artery stenosis or dissection, access site complications, severe vascular complications, and rehospitalization for cardiovascular events. | 6 months after intervention |
| The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up | MACCE includes cardiovascular and cerebrovascular mortality, stroke, and acute heart failure. | 6 months after intervention |