HypertensionPARADISE-HTNNCT05049096
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension
A study testing focused power ultrasound mediate inferior perirenal adipose tussue modification in people with Hypertension and Blood Pressure, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
Trial summary
This randomized, double blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Blood Pressure, Cardiovascular Diseases
- What is being tested?
- focused power ultrasound mediate inferior perirenal adipose tussue modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2021to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual has office systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes；
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 mmHg；
- The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；
- Individual is willing to sign the informed consent of the study.
Who cannot join
- Individual is 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)；
- Individual has history of kidney and or kidney surrounding tissue surgery;
- Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
- Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
- Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
- Individual has uncontrolled thyroid dysfunction;
Show all 16Show fewer
- Individual has urinary calculi and/or hematuria；
- Individual has atrial fibrillation;
- Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease);
- Individual has second degree and above atrioventricular block；
- Individual has abnormal coagulation function;
- Individual has infected waist skin;
- Individual has malignant tumor;
- Individual is pregnant, nursing or planning to be pregnant;
- Individual is unwilling to sign informed consent;
- Individual fails to complete the screening period.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
About this study
Official title: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Double-blinded Controlled Trial. PARADISE Study
This randomized, double blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Read the detailed description
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.
In our previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipse tissue fibrosis and control the blood pressure in the model of swine. Moreover, we 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.
In this study, we aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases
- Being tested
- focused power ultrasound mediate inferior perirenal adipose tussue modification, sham-control group
- Keywords
- Hypertension, Cardiovascular disease, Focused ultrasound, Novel method
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused power ultrasound mediate inferior perirenal adipose tussue modificationDevice
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.
sham-control groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting and initiating) Receives: Device: focused power ultrasound mediate inferior perirenal adipose tussue modification |
| sham-control group | Sham comparator | 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. Receives: Device: sham-control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 1-month compared with baseline
Measured: From baseline to 1 month post-procedure
Secondary outcomes (5)
Office Systolic Blood Pressure
Changes of office blood pressure at 3-month compared with baseline
Measured: From baseline to 3 months post-procedure
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Measured: From baseline to 1 month post-procedure
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline
Measured: From baseline to 3 months post-procedure
Heart Rate
Changes of the heart rate at 1-month compared with baseline
Measured: From baseline to 1 month post-procedure
Mean Heart Rate
Changes of the mean heart rate measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Measured: From baseline to 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Nov 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Why it stopped: Till interim analysis, 100 cases were enrolled, 71 of which during the COVID-19. Affected by epidemic control policy, 58 cases had examination window exceeded or missed, causing significant impact on endpoints, so we decided to terminate the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a ramdomized, double-blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangqing Kong, MD, Principal investigator, Jiangsu province Hospital/The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049096
- Sponsor's protocol ID
- PARADISE-HTN
- Acronym
- PARADISE-HTN
- Status last verified
- Dec 2023
- First submitted
- 7 Sep 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15197016Chandra 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.
PubMed 25190234Djawari D, Haneke E. [Therapy of recurrent oral aphthae with thymopoetin pentapeptide]. Hautarzt. 1983 Sep;34(9):463-4. German.
PubMed 6355012Hua Y, Li MH, Lou YX, Zhang KR, Yang JM, Sheng YH, Zhang YQ, Cheng CL, Zou C, Wu TT, Kong XQ, Sun W. Perirenal fat as a potential marker and therapeutic target for metabolic syndrome: insights from a multicenter randomized controlled trial. Front Endocrinol (Lausanne). 2025 May 23;16:1557701. doi: 10.3389/fendo.2025.1557701. eCollection 2025.
PubMed 40487756Li M, Shi J, Sheng Y, Zhang Y, Wu T, Yang J, Zhang K, Sun W, Kong X. Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study. Trials. 2023 Mar 23;24(1):221. doi: 10.1186/s13063-023-07249-5.
PubMed 36959658
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Double-blinded Controlled Trial. PARADISE Study
- ClinicalTrials.gov ID
- NCT05049096
- Acronym / sponsor ID
- PARADISE-HTN / PARADISE-HTN
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases
- Keywords
- Hypertension, Cardiovascular disease, Focused ultrasound, Novel method
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Till interim analysis, 100 cases were enrolled, 71 of which during the COVID-19. Affected by epidemic control policy, 58 cases had examination window exceeded or missed, causing significant impact on endpoints, so we decided to terminate the trial.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Detailed description
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.
In our previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipse tissue fibrosis and control the blood pressure in the model of swine. Moreover, we 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.
In this study, we aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a ramdomized, double-blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: focused power ultrasound mediate inferior perirenal adipose tussue modificationIn intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting and initiating) |
| sham-control group | Sham comparator | Device: sham-control groupIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individual has office systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes；
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 mmHg；
- The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；
- Individual is willing to sign the informed consent of the study.
Key exclusion criteria (16 listed)
- Individual is 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)；
- Individual has history of kidney and or kidney surrounding tissue surgery;
- Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
- Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
- Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focused power ultrasound mediate inferior perirenal adipose tussue modificationThis 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. | Device | intervention group |
| sham-control groupparticipants 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. | Device | sham-control group |
Primary outcome
Office Systolic Blood Pressure
Time frame: From baseline to 1 month post-procedure
Changes of office systolic blood pressure at 1-month compared with baseline
5 secondary outcomes
Office Systolic Blood Pressure
Time frame: From baseline to 3 months post-procedure
Ambulatory Blood Pressure
Time frame: From baseline to 1 month post-procedure
Ambulatory Blood Pressure
Time frame: From baseline to 3 months post-procedure
Heart Rate
Time frame: From baseline to 1 month post-procedure
Mean Heart Rate
Time frame: From baseline to 1 month post-procedure
Results and safety
The study was stopped early (reason given: Till interim analysis, 100 cases were enrolled, 71 of which during the COVID-19. Affected by epidemic control policy, 58 cases had examination window exceeded or missed, causing significant impact on endpoints, so we decided to terminate the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Results publication: PubMed 15197016Hayashi 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.
- Results publication: PubMed 25190234Chandra 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.
- Results publication: PubMed 6355012Djawari D, Haneke E. [Therapy of recurrent oral aphthae with thymopoetin pentapeptide]. Hautarzt. 1983 Sep;34(9):463-4. German.
- Derived from this study: PubMed 40487756Hua Y, Li MH, Lou YX, Zhang KR, Yang JM, Sheng YH, Zhang YQ, Cheng CL, Zou C, Wu TT, Kong XQ, Sun W. Perirenal fat as a potential marker and therapeutic target for metabolic syndrome: insights from a multicenter randomized controlled trial. Front Endocrinol (Lausanne). 2025 May 23;16:1557701. doi: 10.3389/fendo.2025.1557701. eCollection 2025.
- Derived from this study: PubMed 36959658Li M, Shi J, Sheng Y, Zhang Y, Wu T, Yang J, Zhang K, Sun W, Kong X. Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study. Trials. 2023 Mar 23;24(1):221. doi: 10.1186/s13063-023-07249-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangqing Kong, MD principal investigator
Jiangsu province Hospital/The First Affiliated Hospital of Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused power ultrasound mediate inferior perirenal adipose tussue modification in people with Hypertension and Blood Pressure, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Till interim analysis, 100 cases were enrolled, 71 of which during the COVID-19. Affected by epidemic control policy, 58 cases had examination window exceeded or missed, causing significant impact on endpoints, so we decided to terminate the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office Systolic Blood Pressure (time frame: From baseline to 1 month post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049096, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.