Resistant HypertensionULARHNCT03535532
Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients With Adrenal Diseases
A study testing unilateral laparoscopic adrenalectomy and standard medical treatment in people with Resistant Hypertension and Adrenal Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The purpose of this study is to compare the effectiveness of medical treatment and unilateral laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal disease based on imaging tools.Relative ratio of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resistant Hypertension, Adrenal Disease
- What is being tested?
- unilateral laparoscopic adrenalectomy and standard medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 20 Dec 2018to 20 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resistant hypertensive patients diagnosed with adrenal disease based on imaging tools (resistant hypertension defined as the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg),despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs for at least one month, one of which is represented by a diuretic, in adequate doses)
- Signed the written informed consent.
Who cannot join
- Patients with surgical contraindication;(Performed coronary revascularization (PCI or CABG) within the previous 6 months; Cerebral hemorrhagic stroke within the previous 3 months, or new onset cerebral infarction within the latest 2 weeks;Severe heart failure or kidney disfunction within the previous 6 months)
- Patients who has proceeded unilateral laparoscopic adrenalectomy once;
- Severe somatic disease such as cancer;
- Severe cognitive impairment or mental disorder;
- Participating in other clinical trials.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese Academy of Medical Sciences, FuWai Hospital
Beijing, Beijing Municipality, 100037
Jun Cai, MD
Weili Zhang
Shandong Provincial Hospital
Ji'nan, Shandong, 100037
Shaobo Shaobo
Shaobo Shaobo
Yunzhou Municiple Hospital
Ji'ning, Shandong
Xinhai Wang
Xinhai Wang
About this study
Official title: Effectiveness Comparison of Medical Treatment and Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients Concomitant With Adrenal Diseases: A Prospective, Multi-Center, Open-Labeled, Randomized Clinical Trial.
ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The purpose of this study is to compare the effectiveness of medical treatment and unilateral laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal disease based on imaging tools.Relative ratio of end-point events occurence in three years is considered as primary outcome. Furthermore, we will exploit clinical factors which could indicate a favorable outcome in participants who accepted surgical treatment in this study.
Read the detailed description
Resistant hypertension is a clinical condition characterized by the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg in hypertensive patients), despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs, one of which is represented by a diuretic, in adequate doses. Several small-sample studies suggest the prevalence of resistant hypertension is about 5-30% in Chinese population. Uncontrolled blood pressure elevation attributes to a higher incidence of stroke, heart failure, chronic renal disease, dementia and cardiovascular deaths. Improving the management of resistant hypertension is a constantly tricky problem in hypertension clinical practice.
Compared with patients whose blood pressure level are more easily to get controlled, patients diagnosed with resistant hypertension presented a higher risk of adrenal anomaly when screened by imaging tools. Current clinical practice guidance recommend unilateral laparoscopic adrenalectomy as a preferable treatment merely for adrenal incidentalomas with over hormone secreting like cortisol or aldosterone, or a high likelihood of malignance. Among patients who meet above surgery indication, the ratio of cure for hypertension varies from approximately 30 to 80%. However, in recent years, there are growing evidence showed that hypertensive patients diagnosed with adrenal disease based on imaging tools also gain much benefit from adrenalectomy even if there is no evidently abnormal hormone secretion. Last year, a prospective cohort study published on <Ann Intern Med> suggested that "nonfunctional" adrenal tumors associate with increased diabetes risk. These studies prompt a re-assessment of the classification of benign adrenal tumors as "non-functional"and their potential damage.
In a retrospective study conducted by our group in early period to evaluate the effect of surgery treatment in resistant hypertensive patients, we found one third of resistant hypertensive patients were cured as well as another one third get improved after unilateral laparoscopic adrenalectomy. Thus, we designed this study, expecting a further and more detailed perception of the relationship between resistant hypertension and adrenal anomaly.
- Conditions
- Resistant Hypertension, Adrenal Disease
- Being tested
- unilateral laparoscopic adrenalectomy, standard medical treatment
- Keywords
- resistant hypertension, Adrenal Disease, medical treatment, laparoscopic adrenalectomy
- Medical subject headings
- Adrenal Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral laparoscopic adrenalectomyProcedure or surgery
Also called standard medical treatment
unilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion.
standard medical treatmentDrug
Also called unilateral laparoscopic adrenalectomy
standard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations.
| Study group | Role | What they receive |
|---|---|---|
| unilateral laparoscopic adrenalectomy | Experimental | subjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment. Receives: Procedure: unilateral laparoscopic adrenalectomy |
| standard medical treatment | Active comparator | subjects allocated in standard medical treatment group will be given conservative medicine treatment. Receives: Drug: standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of end-point events
A composite end-point comprised of myocardial infarction(MI), congestive heart failure, cerebrovascular event, end stage renal disease, death.
Measured: 3 year
Secondary outcomes (12)
Major coronary events
Major coronary events comprised of myocardial infarction (MI), hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), and death from cardiovascular causes.
Measured: 3 years
First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)
First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)
Measured: 3 years
All-cause death
All-cause death
Measured: 3 years
Cardiovascular death
Cardiovascular death
Measured: 3 years
myocardial infarction
myocardial infarction
Measured: 3 years
Hospitalization for unstable angina
Hospitalization for unstable angina
Measured: 3 years
Hospitalization for acute decompensated heart failure
Hospitalization for acute decompensated heart failure
Measured: 3 years
coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG])
coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG])
Measured: 3 years
First occurence of diabetes mellitus
First occurence of diabetes mellitus
Measured: 3 years
Decline in cognitive function
Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
Measured: 3 years
Decline in renal functio or development of end stage renal disease (ESRD)
Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR<60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of EDRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decreased in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.
Measured: 3 years
Major artery function changes
Major artery function changes are assessed by a composite of decrease in the ankle branchial index [ABI], brachial-ankle pulse wave velocity(baPWV),or brachial artery flow-mediated dilation [FMD].
ABI and baPWV, well-established non-invasive techniques fr evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.
FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodialator function in humans and is regarded as a surrogate marker of cardiovascular disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start20 Dec 2018 (estimated)
- Primary completion20 Oct 2020 (estimated)
- Study completion20 Dec 2021 (estimated)
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 Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- resistant hypertensive patients diagnosed with adrenal diseases based on imaging tools will be randomly allocated into unilateral laparoscopic adrenalectomy group and standard medical treatment group.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jun Cai, MD, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535532
- Sponsor's protocol ID
- ULARH2017
- Acronym
- ULARH
- Status last verified
- May 2018
- First submitted
- 14 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet
Publications
Sim JJ, Bhandari SK, Shi J, Reynolds K, Calhoun DA, Kalantar-Zadeh K, Jacobsen SJ. Comparative risk of renal, cardiovascular, and mortality outcomes in controlled, uncontrolled resistant, and nonresistant hypertension. Kidney Int. 2015 Sep;88(3):622-32. doi: 10.1038/ki.2015.142. Epub 2015 May 6.
PubMed 25945406Lopez D, Luque-Fernandez MA, Steele A, Adler GK, Turchin A, Vaidya A. "Nonfunctional" Adrenal Tumors and the Risk for Incident Diabetes and Cardiovascular Outcomes: A Cohort Study. Ann Intern Med. 2016 Oct 18;165(8):533-542. doi: 10.7326/M16-0547. Epub 2016 Aug 2.
PubMed 27479926Xu T, Xia L, Wang X, Zhang X, Zhong S, Qin L, Zhang X, Zhu Y, Shen Z. Effectiveness of partial adrenalectomy for concomitant hypertension in patients with nonfunctional adrenal adenoma. Int Urol Nephrol. 2015 Jan;47(1):59-67. doi: 10.1007/s11255-014-0841-8. Epub 2014 Oct 11.
PubMed 25305227Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
PubMed 27390021Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaisse B, Villeneuve F, Halimi JM. [Management of resistant hypertension. Expert consensus statement from the French Society of Hypertension, an affiliate of the French Society of Cardiology]. Presse Med. 2014 Dec;43(12 Pt 1):1325-31. doi: 10.1016/j.lpm.2014.07.016. Epub 2014 Nov 20. French.
PubMed 25459067
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Comparison of Medical Treatment and Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients Concomitant With Adrenal Diseases: A Prospective, Multi-Center, Open-Labeled, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03535532
- Acronym / sponsor ID
- ULARH / ULARH2017
- Conditions
- Resistant Hypertension, Adrenal Disease
- Keywords
- resistant hypertension, Adrenal Disease, medical treatment, laparoscopic adrenalectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 20 Dec 2018 (estimated)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 24 May 2018 (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.
ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The purpose of this study is to compare the effectiveness of medical treatment and unilateral laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal disease based on imaging tools.Relative ratio of end-point events occurence in three years is considered as primary outcome. Furthermore, we will exploit clinical factors which could indicate a favorable outcome in participants who accepted surgical treatment in this study.
Detailed description
Resistant hypertension is a clinical condition characterized by the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg in hypertensive patients), despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs, one of which is represented by a diuretic, in adequate doses. Several small-sample studies suggest the prevalence of resistant hypertension is about 5-30% in Chinese population. Uncontrolled blood pressure elevation attributes to a higher incidence of stroke, heart failure, chronic renal disease, dementia and cardiovascular deaths. Improving the management of resistant hypertension is a constantly tricky problem in hypertension clinical practice.
Compared with patients whose blood pressure level are more easily to get controlled, patients diagnosed with resistant hypertension presented a higher risk of adrenal anomaly when screened by imaging tools. Current clinical practice guidance recommend unilateral laparoscopic adrenalectomy as a preferable treatment merely for adrenal incidentalomas with over hormone secreting like cortisol or aldosterone, or a high likelihood of malignance. Among patients who meet above surgery indication, the ratio of cure for hypertension varies from approximately 30 to 80%. However, in recent years, there are growing evidence showed that hypertensive patients diagnosed with adrenal disease based on imaging tools also gain much benefit from adrenalectomy even if there is no evidently abnormal hormone secretion. Last year, a prospective cohort study published on <Ann Intern Med> suggested that "nonfunctional" adrenal tumors associate with increased diabetes risk. These studies prompt a re-assessment of the classification of benign adrenal tumors as "non-functional"and their potential damage.
In a retrospective study conducted by our group in early period to evaluate the effect of surgery treatment in resistant hypertensive patients, we found one third of resistant hypertensive patients were cured as well as another one third get improved after unilateral laparoscopic adrenalectomy. Thus, we designed this study, expecting a further and more detailed perception of the relationship between resistant hypertension and adrenal anomaly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- resistant hypertensive patients diagnosed with adrenal diseases based on imaging tools will be randomly allocated into unilateral laparoscopic adrenalectomy group and standard medical treatment group.
| Arm | Type | Receives |
|---|---|---|
| unilateral laparoscopic adrenalectomy | Experimental | Procedure: unilateral laparoscopic adrenalectomysubjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment. |
| standard medical treatment | Active comparator | Drug: standard medical treatmentsubjects allocated in standard medical treatment group will be given conservative medicine treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Resistant hypertensive patients diagnosed with adrenal disease based on imaging tools (resistant hypertension defined as the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg),despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs for at least one month, one of which is represented by a diuretic, in adequate doses)
- Signed the written informed consent.
Key exclusion criteria (5 listed)
- Patients with surgical contraindication;(Performed coronary revascularization (PCI or CABG) within the previous 6 months; Cerebral hemorrhagic stroke within the previous 3 months, or new onset cerebral infarction within the latest 2 weeks;Severe heart failure or kidney disfunction within the previous 6 months)
- Patients who has proceeded unilateral laparoscopic adrenalectomy once;
- Severe somatic disease such as cancer;
- Severe cognitive impairment or mental disorder;
- Participating in other clinical trials.
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 |
|---|---|---|
| unilateral laparoscopic adrenalectomyAlso: standard medical treatmentunilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion. | Procedure or surgery | unilateral laparoscopic adrenalectomy |
| standard medical treatmentAlso: unilateral laparoscopic adrenalectomystandard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations. | Drug | standard medical treatment |
Primary outcome
A composite of end-point events
Time frame: 3 year
A composite end-point comprised of myocardial infarction(MI), congestive heart failure, cerebrovascular event, end stage renal disease, death.
12 secondary outcomes
Major coronary events
Time frame: 3 years
First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)
Time frame: 3 years
All-cause death
Time frame: 3 years
Cardiovascular death
Time frame: 3 years
myocardial infarction
Time frame: 3 years
Hospitalization for unstable angina
Time frame: 3 years
Hospitalization for acute decompensated heart failure
Time frame: 3 years
coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG])
Time frame: 3 years
First occurence of diabetes mellitus
Time frame: 3 years
Decline in cognitive function
Time frame: 3 years
Decline in renal functio or development of end stage renal disease (ESRD)
Time frame: 3 years
Major artery function changes
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Background: PubMed 25945406Sim JJ, Bhandari SK, Shi J, Reynolds K, Calhoun DA, Kalantar-Zadeh K, Jacobsen SJ. Comparative risk of renal, cardiovascular, and mortality outcomes in controlled, uncontrolled resistant, and nonresistant hypertension. Kidney Int. 2015 Sep;88(3):622-32. doi: 10.1038/ki.2015.142. Epub 2015 May 6.
- Background: PubMed 27479926Lopez D, Luque-Fernandez MA, Steele A, Adler GK, Turchin A, Vaidya A. "Nonfunctional" Adrenal Tumors and the Risk for Incident Diabetes and Cardiovascular Outcomes: A Cohort Study. Ann Intern Med. 2016 Oct 18;165(8):533-542. doi: 10.7326/M16-0547. Epub 2016 Aug 2.
- Background: PubMed 25305227Xu T, Xia L, Wang X, Zhang X, Zhong S, Qin L, Zhang X, Zhu Y, Shen Z. Effectiveness of partial adrenalectomy for concomitant hypertension in patients with nonfunctional adrenal adenoma. Int Urol Nephrol. 2015 Jan;47(1):59-67. doi: 10.1007/s11255-014-0841-8. Epub 2014 Oct 11.
- Background: PubMed 27390021Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
- Background: PubMed 25459067Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaisse B, Villeneuve F, Halimi JM. [Management of resistant hypertension. Expert consensus statement from the French Society of Hypertension, an affiliate of the French Society of Cardiology]. Presse Med. 2014 Dec;43(12 Pt 1):1325-31. doi: 10.1016/j.lpm.2014.07.016. Epub 2014 Nov 20. French.
- Individual participant dataSharing planned: Undecided. Undecided yet
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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.
Jun Cai, MD study director
Chinese Academy of Medical Sciences, Fuwai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral laparoscopic adrenalectomy and standard medical treatment in people with Resistant Hypertension and Adrenal Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 2 inclusion and 5 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 24 May 2018. 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. 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 Weili Zhang, MD (861088322025, zhangweili1747@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of end-point events (time frame: 3 year). 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 NCT03535532, 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 24 May 2018.