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| Name | Class |
|---|---|
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
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This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.
Heart failure is one of the most important diseases worldwide, with a 5-year mortality of up to 75% in symptomatic patients. While substantial progress has been made in the treatment of patients with reduced left ventricular ejection fraction (HFrEF), mortality for patients with heart failure and preserved ejection fraction (HFpEF) remains unchanged, despite a comparable prevalence and mortality of the disease as for heart failure with reduced ejection fraction. Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation and maintenance of heart failure medications | Experimental | Renal denervation in patients with HFpEF and uncontrolled hypertension |
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| Sham intervention, maintenance of heart failure medications | Sham Comparator | Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham procedure and maintenance of heart failure medications | Procedure | Sham intervention, maintenance of heart failure medications |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline E/E' at 12 months | Echocardiography will be used to measure the E/E' | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Xie | Contact | +869914366892 | xiangxie999@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Renal denervation and maintenance of heart failure medications | Procedure | Renal denervation and maintenance of heart failure medications |
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