Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06283758
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'Any adverse events (AE) or severe adverse events (SAE) related to intervention. The SAE were defined as acute renal failure, acute intestinal perforation, and thromboembolic events, et al.'}], 'primaryOutcomes': [{'measure': 'Ambulatory Blood Pressure', 'timeFrame': 'From baseline to 1 month post-procedure', 'description': 'Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline'}], 'secondaryOutcomes': [{'measure': 'Ambulatory Blood Pressure', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline'}, {'measure': 'Office Systolic Blood Pressure', 'timeFrame': 'From baseline to 1 month post-procedure', 'description': 'Changes of office systolic blood pressure at 1-month compared with baseline'}, {'measure': 'Office Systolic Blood Pressure', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'Changes of office systolic blood pressure at 3-month compared with baseline'}, {'measure': 'Ambulatory Blood Pressure', 'timeFrame': 'From baseline to 1 month post-procedure', 'description': 'Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline'}, {'measure': 'Ambulatory Blood Pressure', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline'}, {'measure': 'Home Blood Pressure', 'timeFrame': 'From baseline to 1 month post-procedure', 'description': 'Changes of home blood pressure at 1-month compared with baseline'}, {'measure': 'Home Blood Pressure', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'Changes of home blood pressure at 3-month compared with baseline'}, {'measure': 'Blood pressure control rate', 'timeFrame': 'From baseline to 3 month post-procedure', 'description': 'The control rate of blood pressure (defined as office systolic blood pressure\\<140/90mmHg) at 3-month'}, {'measure': 'Antihypertensive drug load index', 'timeFrame': 'From baseline to 1 month and 3 month post-procedure', 'description': 'Changes of antihypertensive drug load index at 1-month and 3-month compared with baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Cardiovascular diseases', 'Focused ultrasound', 'Novel method'], 'conditions': ['Hypertension', 'Blood Pressure', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '15197016', 'type': 'BACKGROUND', 'citation': 'Hayashi T, Boyko EJ, Leonetti DL, McNeely MJ, Newell-Morris L, Kahn SE, Fujimoto WY. Visceral adiposity is an independent predictor of incident hypertension in Japanese Americans. Ann Intern Med. 2004 Jun 15;140(12):992-1000. doi: 10.7326/0003-4819-140-12-200406150-00008.'}, {'pmid': '25190234', 'type': 'BACKGROUND', 'citation': 'Chandra A, Neeland IJ, Berry JD, Ayers CR, Rohatgi A, Das SR, Khera A, McGuire DK, de Lemos JA, Turer AT. The relationship of body mass and fat distribution with incident hypertension: observations from the Dallas Heart Study. J Am Coll Cardiol. 2014 Sep 9;64(10):997-1002. doi: 10.1016/j.jacc.2014.05.057.'}, {'pmid': '16355012', 'type': 'BACKGROUND', 'citation': 'Hutley L, Prins JB. Fat as an endocrine organ: relationship to the metabolic syndrome. Am J Med Sci. 2005 Dec;330(6):280-9. doi: 10.1097/00000441-200512000-00005.'}, {'pmid': '35668093', 'type': 'BACKGROUND', 'citation': 'Li P, Liu B, Wu X, Lu Y, Qiu M, Shen Y, Tian Y, Liu C, Chen X, Yang C, Deng M, Wang Y, Gu J, Su Z, Chen X, Zhao K, Sheng Y, Zhang S, Sun W, Kong X. Perirenal adipose afferent nerves sustain pathological high blood pressure in rats. Nat Commun. 2022 Jun 6;13(1):3130. doi: 10.1038/s41467-022-30868-6.'}]}, 'descriptionModule': {'briefSummary': 'This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.', 'detailedDescription': "The increase of visceral fat is closely related to the occurrence of hypertension, and it is one of the main independent risk factors of hypertension. Visceral fat has been recognized as an important endocrine organ, and a variety of factors secreted by visceral fat lead to an increased risk of cardiovascular disease. Peri-renal fat is a special type of visceral fat which is different from other type of visceral fat in histology, physiology, and functions. The positon of peri-renal fat is more stable than other visceral fat, which might be influenced by breath or body position changes. Studies have found that perirenal fat is an early predictor of ASCVD, and its accumulation is closely related to the occurrence and development of ASCVD. Therefore, the reduction or modification of visceral fat, especially peri-renal fat, has a sufficient scientific basis for the treatment of hypertension.\n\nIn the investigators' previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipose tissue fibrosis and control the blood pressure in the model of swine. Moreover, the investigators performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior perirenal adipose tissue in human volunteers, showing that this kind of method was feasible and safe.\n\nThis seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. In Stage 1, 30 participants will be 1:1:1 randomly allocated to 3 intervention groups (single treatment group, consecutive treatment group A, and consecutive treatment group B). The optimal treatment strategy will be selected based on the decrease of blood pressure and safety evaluation and proceed to Stage 2. In Stage 2, participants will be randomly assigned to intervention group (optimal treatment strategy selected formerly in Stage 1) and sham control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and \\<160 mmHg, and office diastolic blood pressure (DBP)\\<100mmHg after standardized antihypertensive drug treatment for 1 month;\n2. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥130 mmHg；\n3. The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；\n4. Individual is willing to sign the informed consent of the study.\n\nExclusion Criteria:\n\n1. Individual diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, aortic coarctation, obstructive sleep apnea hypopnea syndrome)；\n2. Individuals with ≥ 3 cardiovascular risk factors (male\\>55 years old, female\\>65 years old; smoking or passive smoking; 2-hour postprandial blood glucose 7.8-11mmol/L and/or impaired fasting glucose (6.1-6.9mmol/L); LDL-C ≥ 3.4mmol/L (130mg/dl), HDL-C\\<1.0mmol/L (40mg/dl) or TC ≥ 5.2mmol/L (200mg/dl); Family history of early onset of cardiovascular disease, age of onset of first degree relatives\\<50 years old; Abdominal obesity, waist circumference: male\\>90cm, female\\>85cm or BMI\\>28kg/m2) or hypertensive target organ damage;\n3. riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM)\n4. Regular night shift workers\n5. Individuals taking other medications that may affect blood pressure (such as glucocorticoids);\n6. Individual with history of kidney or kidney surrounding tissue surgery;\n7. Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);\n8. Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;\n9. Individual with type 1 diabetes or uncontrolled type 2 diabetes；\n10. Individual with uncontrolled thyroid dysfunction;\n11. Individual with urinary calculi or hematuria；\n12. Individual with atrial fibrillation;\n13. Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease);\n14. Individual with second degree and above atrioventricular block and/or sick sinus syndrome;\n15. Individual with abnormal coagulation function;\n16. Individual with infected waist skin;\n17. Individual with claustrophobia；\n18. Individual with malignant tumor;\n19. History of allergy to amlodipine, olmesartan, and hydrochlorothiazide\n20. Individual is pregnant, nursing or planning to be pregnant;\n21. Individual is unwilling to sign informed consent;\n22. Individual fails to complete the screening period."}, 'identificationModule': {'nctId': 'NCT06283758', 'briefTitle': 'Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)', 'organization': {'class': 'OTHER', 'fullName': 'Suzhou Municipal Hospital'}, 'officialTitle': 'Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Controlled Phase II/III Clinical Trial (PARADISE HTN-III)', 'orgStudyIdInfo': {'id': 'PARADISE HTN-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1: Intervention group', 'description': 'This arm is combined with 3 groups and a total of 30 participants will be 1:1:1 allocated (each group with 10 participants).\n\nSingle treatment group: receive treatment once after enrollment; Consecutive treatment group A: receive 3 consecutive treatments, each with an interval of 3 days; Consecutive treatment group B: receive 3 consecutive treatments, each with an interval of 7 days. In Stage 1, the investigators will select optimal treatment strategy and proceed to Stage 2.', 'interventionNames': ['Device: focused power ultrasound mediate inferior perirenal adipose tissue modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2: Intervention group', 'description': 'Participants will receive optimal treatment strategy selected formerly in Stage 1', 'interventionNames': ['Device: focused power ultrasound mediate inferior perirenal adipose tissue modification']}, {'type': 'SHAM_COMPARATOR', 'label': 'Stage 2: Sham-control group', 'description': 'In sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.', 'interventionNames': ['Device: Sham-control group']}], 'interventions': [{'name': 'focused power ultrasound mediate inferior perirenal adipose tissue modification', 'type': 'DEVICE', 'description': 'This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.', 'armGroupLabels': ['Stage 1: Intervention group', 'Stage 2: Intervention group']}, {'name': 'Sham-control group', 'type': 'DEVICE', 'description': 'Participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.', 'armGroupLabels': ['Stage 2: Sham-control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuqing Zhang', 'role': 'CONTACT', 'phone': '13851672168'}, {'name': 'Qin Tao', 'role': 'CONTACT', 'phone': '1585062208'}, {'name': 'Yuqing Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Affiliated Jiangning Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Zhou', 'role': 'CONTACT', 'email': 'zhoufang7408@163.com', 'phone': '13815401066'}, {'name': 'Wei Sun', 'role': 'CONTACT', 'email': 'shunwee@126.com', 'phone': '13815860536'}, {'name': 'Fang Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The first Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210000', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongzhuan Sheng', 'role': 'CONTACT', 'phone': '13515203348'}, {'name': 'Jian Zhuo', 'role': 'CONTACT', 'phone': '18206297131'}, {'name': 'Hongzhuan Sheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '210000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanhui Sheng', 'role': 'CONTACT', 'email': 'yhshengnjmu@163.com', 'phone': '13851647530'}, {'name': 'Yang Hua', 'role': 'CONTACT', 'email': '759150674@qq.com', 'phone': '13851624359'}, {'name': 'Yanhui Sheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Suzhou Municipal Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Yanhui Sheng', 'role': 'CONTACT', 'email': 'yhsheng@njmu.edu.cn', 'phone': '13851647530'}, {'name': 'Yang Hua', 'role': 'CONTACT', 'email': '759150674@qq.com', 'phone': '13851624359'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Municipal Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Jiangning Hospital of Nanjing Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Department of Cardiovascular medicine', 'investigatorFullName': 'Yanhui Sheng', 'investigatorAffiliation': 'Suzhou Municipal Hospital'}}}}