A prospective study to evaluate the safety and the efficacy of blood pressure reduction of Laparoscopic RDN in patients with resistant hypertensio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009209
- Lead Sponsor
- DeepQure
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Subjects are deemed eligible for this clinical trial only if they meet all of the following criteria:
1) Male and female patients aged between 19 and 80 years old
2) Resistant hypertensive patients on stable regimen of at least 3 antihypertensive medications* for at least 4weeks prior Screening1 and those who are willing to continue existing antihypertensive medications during run-in period and till 3 months after surgery from Screening 1
* Patients on at least 3 antihypertensive medications of different classis including diuretics
3) Those who meet the following blood pressure requirements:
[Screening 1]
?Office systolic blood pressure (SBP) = 140 mmHg
?Office diastolic blood pressure (SBP) = 90 mmHg
[Screening 2]
?Office SBP = 140 mmHg
?Office DBP = 90 mmHg
?Daytime ASBP = 135 mmHg
4) Those who have the ability and willingness to provide voluntary and written consent to participate in this clinical trial
Subjects cannot be enrolled in the clinical trial if they meet any of the following criteria:
1) Those with the following confirmed anatomical findings in the kidney or renal artery that are unsuitable for renal denervation (assessed based on the results of the renal CT angiography of Screening 2)
?If there is an atheroma or renal artery stent within 5 mm of the renal denervation site
?Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy
?When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator
2) Those with a medical history or a history of surgery/procedure that is unsuitable for renal denervation therapy
?Renal denervation therapy
?Renal artery stenting within 3 months prior to surgery
?Polycystic kidney disease (PKD)
?Atrophic kidney
?Kidney transplant
?Dialysis due to end-stage renal disease
?Any surgery performed on the both kidney
?FMD(Fibromuscular dysplasia)
3) Those with a confirmed comorbidity or a history of surgery/procedure that is unsuitable for posterior retroperitoneal approach required for renal denervation therapy
?Surgical history using the retroperitoneal approach
?Fibrosis of the retroperitoneal region
?Inflammation of the retroperitoneal region
?Extreme obesity (body mass index (BMI) > 40 kg/m2)
?Risk of elevated intracranial pressure
4) eGFR* < 45 mL/min/1.73 m2
* eGFR calculation formula (MDRD equation)
175 × (sCr)-1.154 × (age)-0.203 × (0.742 if female)
5) Those with type 1 diabetes or uncontrolled type 2 diabetes*
* Uncontrolled type 2 diabetes: HbA1c = 8.0%
* HbA1c will be tested in Screening 2 if the confirmed HbA1c result is from the test conducted 3 months before Screening 2 or if additional tests are deemed necessary according to the investigator discretion due to a history of inadequately controlled blood glucose level.
6) Those who receive SGLT2 inhibitors or GLP-1 agonists within 90 days before Screening 1, or those who are expected to require treatment during the clinical trial period(but if on continuous medication without changes more than 90days can be enrolled)
7) Those with at least a 20-mmHg decrease in office SBP or at least a 10-mmHg decrease in office DBP accompanied by symptoms, measured within 3 minutes of standing up during Screening 2(but if orthostatic hypotension is clearly due to BPH, surject can be enrolled)
8) Those who are likely to experience safety problems due to blood pressure drop according to the discretion of the investigator (e.g., heart valve stenosis, peripheral vascular disease, aortic aneurysm, and high-risk groups for bleeding (thrombocytopenia, hemophilia, severe anemia, etc.)
9) Those who have difficulty in measuring blood pressure accurately according to the discretion of the investigator (e.g., if the circumference of the upper arm is larger than the cuff size of the blood pressure monitor, those with arrhythmia, etc.)
10) Those who have secondary hypertension or are receiving sympathomimetic drugs that affect hypertension
11)Those with a history of the following cardiovascular diseases or accompanying diseases
Administration of aspirin and clopidogrel to lower the risk of cardiovascular disease is allowed.
?Myocardial infarction occurring within 3 months prior to Screening 1
?Stable/Unstable angina occurring within 3 months prior to
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in 24-h ASBP from baseline at 3 months post RD
- Secondary Outcome Measures
Name Time Method