Primary AldosteronismNCT06597630
Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Qifu Li at 1 site in China.
Trial summary
1. Aim to investigate the pathological feature of UPA in Asians 2. To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians. 3. To explore a new pathological type of unilateral primary aldosterone Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Tissue specimens were stained by histopathology of hematoxylin-eosin
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, about 100 patients with unilateral protonaldehydes undergoing total adrenal resection will be continuously enrolled in this research center from December 2023. Unilateral Primary Aldosteronism underwent total Adrenalectomy were continuously included
Who may be able to join
- No gender limitation;
- Age 18-80 years old;
- The patient was diagnosed with UPA and underwent total adrenal resection.
Who cannot join
- Bilateral disease
- Partial of no biochemical response in follow-up
- partial adrenalectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qifu Li, PhD
Chongqing, Chongqing Municipality, 400016
Li Qifu, PhD, 18696676815 ext. +86, liqifu@yeah.net
About this study
Official title: Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism，A Prospective Study
- Aim to investigate the pathological feature of UPA in Asians
- To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians.
- To explore a new pathological type of unilateral primary aldosterone
Read the detailed description
The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.
- Conditions
- Primary Aldosteronism
- Being tested
- Tissue specimens were stained by histopathology of hematoxylin-eosin
- Keywords
- Pathological type, Gene mutation
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue specimens were stained by histopathology of hematoxylin-eosinOther
Also called Tissue specimens were stained by CYP11B2
Whole slide images were created by scanning the complete histologic slide to produce high-resolution digital files of the histopathology of hematoxylin-eosin and CYP11B2 immunostained sections.Tissue sections of all blocks from each resected adrenal were evaluated by hematoxylin and eosin and CYP11B2 immunostaining and adrenal specimens were categorized as classical or nonclassical histopathologic findings of unilateral PA according to the HISTALDO consensus; Genotyping was performed using CYP11B2 (aldosterone synthase)-guided sequencing
| Study group | Role | What they receive |
|---|---|---|
| unilateral primary aldosteronism group | The patient was diagnosed with unilateral primary aldosteronism and underwent total adrenal resection Receives: Other: Tissue specimens were stained by histopathology of hematoxylin-eosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Measured: 2 weeks after surgery
The proportion with genetic mutations
The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Measured: 2 weeks after surgery
Analyze the Aldosterone level and renin level Characteristics
Aldosterone level（pg/ml）, renin level（uIU/ml）, blood potassium（mmol/L） and blood pressure are the main clinical indicators of primary aldosteronism(Aldosterone level divided by renin level to obtain ARR, ARR greater than 20 consider whether aldosterone autonomic secretion),different pathological types of aldosteronomas were measured to analyze whether there were differences in clinical characteristics of adrenal tumors of different pathological types
Measured: 2 weeks after surgery
Secondary outcomes (2)
Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Measured: 2 weeks after surgery
Analyze the blood potassium and blood pressure Characteristics
Primary aldosterone has varying degrees of hypertension with or without hypokalemia
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qifu Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qifu Li, Chongqing Medical University
- Investigators
- Li Qifu, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597630
- Sponsor's protocol ID
- PGC-UPA-2024
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7.
PubMed 18314347Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.
PubMed 29129575Yang Y, Xiao M, Song Y, Tang Y, Luo T, Yang S, He W, Cheng Q, Ma L, Zhang Y, He Y, Cao Y, Yang J, Peng B, Hu J, Li Q. H-score of 11beta-hydroxylase and aldosterone synthase in the histopathological diagnosis of adrenocortical tumors. Endocrine. 2019 Sep;65(3):683-691. doi: 10.1007/s12020-019-02022-8. Epub 2019 Jul 22.
PubMed 31332713Yamazaki Y, Omata K, Tezuka Y, Ono Y, Morimoto R, Adachi Y, Ise K, Nakamura Y, Gomez-Sanchez CE, Shibahara Y, Kitamoto T, Nishikawa T, Ito S, Satoh F, Sasano H. Tumor Cell Subtypes Based on the Intracellular Hormonal Activity in KCNJ5-Mutated Aldosterone-Producing Adenoma. Hypertension. 2018 Sep;72(3):632-640. doi: 10.1161/HYPERTENSIONAHA.118.10907.
PubMed 30354756Sun N, Meyer LS, Feuchtinger A, Kunzke T, Knosel T, Reincke M, Walch A, Williams TA. Mass Spectrometry Imaging Establishes 2 Distinct Metabolic Phenotypes of Aldosterone-Producing Cell Clusters in Primary Aldosteronism. Hypertension. 2020 Mar;75(3):634-644. doi: 10.1161/HYPERTENSIONAHA.119.14041. Epub 2020 Jan 20.
PubMed 31957522Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.
PubMed 32327102Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
PubMed 28385310Funder JW. Primary aldosteronism as a public health issue. Lancet Diabetes Endocrinol. 2016 Dec;4(12):972-973. doi: 10.1016/S2213-8587(16)30272-8. No abstract available.
PubMed 27886747Mete O, Asa SL, Giordano TJ, Papotti M, Sasano H, Volante M. Immunohistochemical Biomarkers of Adrenal Cortical Neoplasms. Endocr Pathol. 2018 Jun;29(2):137-149. doi: 10.1007/s12022-018-9525-8.
PubMed 29542002Nishimoto K, Koga M, Seki T, Oki K, Gomez-Sanchez EP, Gomez-Sanchez CE, Naruse M, Sakaguchi T, Morita S, Kosaka T, Oya M, Ogishima T, Yasuda M, Suematsu M, Kabe Y, Omura M, Nishikawa T, Mukai K. Immunohistochemistry of aldosterone synthase leads the way to the pathogenesis of primary aldosteronism. Mol Cell Endocrinol. 2017 Feb 5;441:124-133. doi: 10.1016/j.mce.2016.10.014. Epub 2016 Oct 14.
PubMed 27751767Gomez-Sanchez CE, Kuppusamy M, Reincke M, Williams TA. Disordered CYP11B2 Expression in Primary Aldosteronism. Horm Metab Res. 2017 Dec;49(12):957-962. doi: 10.1055/s-0043-122238. Epub 2017 Dec 4.
PubMed 29202495Nishimoto K, Nakagawa K, Li D, Kosaka T, Oya M, Mikami S, Shibata H, Itoh H, Mitani F, Yamazaki T, Ogishima T, Suematsu M, Mukai K. Adrenocortical zonation in humans under normal and pathological conditions. J Clin Endocrinol Metab. 2010 May;95(5):2296-305. doi: 10.1210/jc.2009-2010. Epub 2010 Mar 3.
PubMed 20200334Williams TA, Gomez-Sanchez CE, Rainey WE, Giordano TJ, Lam AK, Marker A, Mete O, Yamazaki Y, Zerbini MCN, Beuschlein F, Satoh F, Burrello J, Schneider H, Lenders JWM, Mulatero P, Castellano I, Knosel T, Papotti M, Saeger W, Sasano H, Reincke M. International Histopathology Consensus for Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2021 Jan 1;106(1):42-54. doi: 10.1210/clinem/dgaa484.
PubMed 32717746Monticone S, Castellano I, Versace K, Lucatello B, Veglio F, Gomez-Sanchez CE, Williams TA, Mulatero P. Immunohistochemical, genetic and clinical characterization of sporadic aldosterone-producing adenomas. Mol Cell Endocrinol. 2015 Aug 15;411:146-54. doi: 10.1016/j.mce.2015.04.022. Epub 2015 May 6.
PubMed 25958045Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.
PubMed 28576687
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism，A Prospective Study
- ClinicalTrials.gov ID
- NCT06597630
- Acronym / sponsor ID
- PGC-UPA-2024
- Conditions
- Primary Aldosteronism
- Keywords
- Pathological type, Gene mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qifu LiUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
- Aim to investigate the pathological feature of UPA in Asians
- To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians.
- To explore a new pathological type of unilateral primary aldosterone
Detailed description
The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral primary aldosteronism group | – | Other: Tissue specimens were stained by histopathology of hematoxylin-eosinThe patient was diagnosed with unilateral primary aldosteronism and underwent total adrenal resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, about 100 patients with unilateral protonaldehydes undergoing total adrenal resection will be continuously enrolled in this research center from December 2023. Unilateral Primary Aldosteronism underwent total Adrenalectomy were continuously included
Key inclusion criteria (3 listed)
- No gender limitation;
- Age 18-80 years old;
- The patient was diagnosed with UPA and underwent total adrenal resection.
Key exclusion criteria (3 listed)
- Bilateral disease
- Partial of no biochemical response in follow-up
- partial adrenalectomy
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 |
|---|---|---|
| Tissue specimens were stained by histopathology of hematoxylin-eosinAlso: Tissue specimens were stained by CYP11B2Whole slide images were created by scanning the complete histologic slide to produce high-resolution digital files of the histopathology of hematoxylin-eosin and CYP11B2 immunostained sections.Tissue sections of all blocks from each resected adrenal were evaluated by hematoxylin and eosin and CYP11B2 immunostaining and adrenal specimens were categorized as classical or nonclassical histopathologic findings of unilateral PA according to the HISTALDO consensus; Genotyping was performed using CYP11B2 (aldosterone synthase)-guided sequencing | Other | unilateral primary aldosteronism group |
Primary outcome
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
Time frame: 2 weeks after surgery
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
The proportion with genetic mutations
Time frame: 2 weeks after surgery
The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Analyze the Aldosterone level and renin level Characteristics
Time frame: 2 weeks after surgery
Aldosterone level（pg/ml）, renin level（uIU/ml）, blood potassium（mmol/L） and blood pressure are the main clinical indicators of primary aldosteronism(Aldosterone level divided by renin level to obtain ARR, ARR greater than 20 consider whether aldosterone autonomic secretion),different pathological types of aldosteronomas were measured to analyze whether there were differences in clinical characteristics of adrenal tumors of different pathological types
2 secondary outcomes
Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions
Time frame: 2 weeks after surgery
Analyze the blood potassium and blood pressure Characteristics
Time frame: 2 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 18314347Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7.
- Background: PubMed 29129575Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.
- Background: PubMed 31332713Yang Y, Xiao M, Song Y, Tang Y, Luo T, Yang S, He W, Cheng Q, Ma L, Zhang Y, He Y, Cao Y, Yang J, Peng B, Hu J, Li Q. H-score of 11beta-hydroxylase and aldosterone synthase in the histopathological diagnosis of adrenocortical tumors. Endocrine. 2019 Sep;65(3):683-691. doi: 10.1007/s12020-019-02022-8. Epub 2019 Jul 22.
- Background: PubMed 30354756Yamazaki Y, Omata K, Tezuka Y, Ono Y, Morimoto R, Adachi Y, Ise K, Nakamura Y, Gomez-Sanchez CE, Shibahara Y, Kitamoto T, Nishikawa T, Ito S, Satoh F, Sasano H. Tumor Cell Subtypes Based on the Intracellular Hormonal Activity in KCNJ5-Mutated Aldosterone-Producing Adenoma. Hypertension. 2018 Sep;72(3):632-640. doi: 10.1161/HYPERTENSIONAHA.118.10907.
- Background: PubMed 31957522Sun N, Meyer LS, Feuchtinger A, Kunzke T, Knosel T, Reincke M, Walch A, Williams TA. Mass Spectrometry Imaging Establishes 2 Distinct Metabolic Phenotypes of Aldosterone-Producing Cell Clusters in Primary Aldosteronism. Hypertension. 2020 Mar;75(3):634-644. doi: 10.1161/HYPERTENSIONAHA.119.14041. Epub 2020 Jan 20.
- Results publication: PubMed 32327102Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.
- Results publication: PubMed 28385310Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
- Results publication: PubMed 27886747Funder JW. Primary aldosteronism as a public health issue. Lancet Diabetes Endocrinol. 2016 Dec;4(12):972-973. doi: 10.1016/S2213-8587(16)30272-8. No abstract available.
- Results publication: PubMed 29542002Mete O, Asa SL, Giordano TJ, Papotti M, Sasano H, Volante M. Immunohistochemical Biomarkers of Adrenal Cortical Neoplasms. Endocr Pathol. 2018 Jun;29(2):137-149. doi: 10.1007/s12022-018-9525-8.
- Results publication: PubMed 27751767Nishimoto K, Koga M, Seki T, Oki K, Gomez-Sanchez EP, Gomez-Sanchez CE, Naruse M, Sakaguchi T, Morita S, Kosaka T, Oya M, Ogishima T, Yasuda M, Suematsu M, Kabe Y, Omura M, Nishikawa T, Mukai K. Immunohistochemistry of aldosterone synthase leads the way to the pathogenesis of primary aldosteronism. Mol Cell Endocrinol. 2017 Feb 5;441:124-133. doi: 10.1016/j.mce.2016.10.014. Epub 2016 Oct 14.
- Results publication: PubMed 29202495Gomez-Sanchez CE, Kuppusamy M, Reincke M, Williams TA. Disordered CYP11B2 Expression in Primary Aldosteronism. Horm Metab Res. 2017 Dec;49(12):957-962. doi: 10.1055/s-0043-122238. Epub 2017 Dec 4.
- Results publication: PubMed 20200334Nishimoto K, Nakagawa K, Li D, Kosaka T, Oya M, Mikami S, Shibata H, Itoh H, Mitani F, Yamazaki T, Ogishima T, Suematsu M, Mukai K. Adrenocortical zonation in humans under normal and pathological conditions. J Clin Endocrinol Metab. 2010 May;95(5):2296-305. doi: 10.1210/jc.2009-2010. Epub 2010 Mar 3.
- Individual participant dataSharing planned: No
Related trials for Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
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.
Li Qifu study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Qifu Li at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Qifu (02389011552, liqifu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions (time frame: 2 weeks after surgery). The study lists 3 primary outcomes in all. 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 NCT06597630, which also lists 15 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 19 Sep 2024.