Primary AldosteronismNCT06192810
Short- and Long-term Outcomes of Adrenalectomy for Primary Aldosteronism
An observational study of Primary Aldosteronism, run by University College London Hospitals.
Trial summary
The proposed study is this. Short- and long-term outcomes of adrenalectomy for Primary Aldosteronism (PA) in a single centre. PA is a relatively common problem and considers as the commonest cause of secondary hypertension and can be successfully treated by adrenalectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Laparoscopic/open adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1998to 1 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults diagnosed with primary aldosteronism and underwent surgical treatment
Who may be able to join
- Patient underwent adrenalectomy as a management of primary aldosteronism
- Patient available for short term and long term follow up
Who cannot join
- medically treated patients
- not available for follow up
About this study
Official title: Short- and Long-Term Outcomes of Adrenalectomy for Primary Aldosteronism in a Single UK Centre: Rear Mirror View
The proposed study is this. Short- and long-term outcomes of adrenalectomy for Primary Aldosteronism (PA) in a single centre. PA is a relatively common problem and considers as the commonest cause of secondary hypertension and can be successfully treated by adrenalectomy.
The investigators aim to gather clinical data routinely collected on participants with primary aldosteronism pre-operatively and post-operatively for a short and long term follow up.
Read the detailed description
Retrospective analysis of data from a prospectively maintained database of participants with PA who underwent surgery between 1st January 1998 and 31st December 2022 at University College London Hospital, a tertiary referral centre for endocrinology and endocrine surgery.
The clinical pathway for screening, diagnosis and stratification for adrenalectomy varied through the 24 years and was based on concurrent recommendations, published evidence, changing local expertise and best practice at the time. Throughout this period diagnosis of PA in our centre was based on the presence of hypertension and hypokalaemia, high aldosterone level, suppressed renin activity and aldosterone and renin ratio (ARR) above 850. Currently a confirmatory test (for example, saline suppression test) recommended if the aldosterone is <550pmol/L but in the upper third of the normal range or the plasma renin is non-suppressed unless the patient presents with spontaneous hypokalaemia, plasma renin below detection levels and aldosterone concentration more than 550 pmol/L.
Stratification for adrenalectomy, once a diagnosis of PA was confirmed, included cross sectional imaging of adrenals with computed tomography (CT) or magnetic resonance imaging (MRI). Adrenal venous sampling (AVS) and/or later 11C Metomidate positron emission tomography-CT (PET-CT) scan was performed if imaging showed bilateral adrenal nodules. Surgery was recommended after discussion in the multidisciplinary team meeting (endocrinologist, endocrine surgeon, biochemists and radiologist).
During the very beginning of the study laparoscopic adrenalectomy was introduced and transperitoneal lateral technique was used to perform laparoscopic adrenalectomy using 3 ports on the left and 4 ports on the right side.
Participants included in the study were characterised preoperatively by their demographics (age, sex and ethnicity) clinical presentation (blood pressure), number of antihypertensive medications and biochemical tests (potassium, aldosterone, renin, ARR ratio).
Number and type of investigations (CT, MRI, AVS, Metomidate) used to stratify for surgery and the size of the adrenal nodules on cross sectional imaging was recorded. Process of stratification was presented as lateralisation to the left or right reached as a consensus between cross sectional imaging, AVS and nuclear medicine imaging.
Data on post operative surgical outcomes included conversion rate to open adrenalectomy, postoperative complications (Clavien-Dindo)and length of hospital stay.
Postoperative outcomes were assessed within 3 months of surgery (short term) and at least 60 months (long term). Data collected were blood pressure, number of antihypertensive medications, plasma concentration of potassium, aldosterone, renin and ARR ratio. Surgical outcomes were categorised using primary aldosteronism surgical outcome score (PASO) criteria of complete, partial or absent success for both clinical and biochemical cure which reflected remission, improvement or persistence of disease.
- Conditions
- Primary Aldosteronism
- Being tested
- Laparoscopic/open adrenalectomy
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic/open adrenalectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure
Short- and long-term clinical changes for the following parameter:
-Systolic and diastolic blood pressure measured in mmHg
Measured: 3 months for short term and 5 years for long term
Short- and long-term assessment of clinical improvement in number of antihypertensive medications in participants
Short- and long-term clinical changes for the following parameter:
-Number of antihypertensive medications
Measured: 3 months for short term and 5 years for long term
Secondary outcomes (4)
Short- and long-term assessment of biochemical improvement in serum potassium level in participants
Short-and long-term changes in biochemical parameter:
-Serum Potassium level measured in mmol/L
Measured: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Aldosterone level in participants
Short-and long-term changes in biochemical parameter:
-Serum Aldosterone level measured in pmol/L
Measured: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Renin level in participants
Short-and long-term changes in biochemical parameter:
-Serum Renin level measured in nmol/L
Measured: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Aldosterone/Renin ratio (ARR) (pmol/nmol/L) level in participants
Short-and long-term changes in biochemical parameters:
-Serum Aldosterone/Renin ratio ARR (pmol/nmol/L)
Measured: 3 months for short term and 5 years for long term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 1998
- Primary completion31 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelsalam, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192810
- Sponsor's protocol ID
- 157714
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-Term Outcomes of Adrenalectomy for Primary Aldosteronism in a Single UK Centre: Rear Mirror View
- ClinicalTrials.gov ID
- NCT06192810
- Acronym / sponsor ID
- 157714
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 5 Jan 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.
The proposed study is this. Short- and long-term outcomes of adrenalectomy for Primary Aldosteronism (PA) in a single centre. PA is a relatively common problem and considers as the commonest cause of secondary hypertension and can be successfully treated by adrenalectomy.
The investigators aim to gather clinical data routinely collected on participants with primary aldosteronism pre-operatively and post-operatively for a short and long term follow up.
Detailed description
Retrospective analysis of data from a prospectively maintained database of participants with PA who underwent surgery between 1st January 1998 and 31st December 2022 at University College London Hospital, a tertiary referral centre for endocrinology and endocrine surgery.
The clinical pathway for screening, diagnosis and stratification for adrenalectomy varied through the 24 years and was based on concurrent recommendations, published evidence, changing local expertise and best practice at the time. Throughout this period diagnosis of PA in our centre was based on the presence of hypertension and hypokalaemia, high aldosterone level, suppressed renin activity and aldosterone and renin ratio (ARR) above 850. Currently a confirmatory test (for example, saline suppression test) recommended if the aldosterone is <550pmol/L but in the upper third of the normal range or the plasma renin is non-suppressed unless the patient presents with spontaneous hypokalaemia, plasma renin below detection levels and aldosterone concentration more than 550 pmol/L.
Stratification for adrenalectomy, once a diagnosis of PA was confirmed, included cross sectional imaging of adrenals with computed tomography (CT) or magnetic resonance imaging (MRI). Adrenal venous sampling (AVS) and/or later 11C Metomidate positron emission tomography-CT (PET-CT) scan was performed if imaging showed bilateral adrenal nodules. Surgery was recommended after discussion in the multidisciplinary team meeting (endocrinologist, endocrine surgeon, biochemists and radiologist).
During the very beginning of the study laparoscopic adrenalectomy was introduced and transperitoneal lateral technique was used to perform laparoscopic adrenalectomy using 3 ports on the left and 4 ports on the right side.
Participants included in the study were characterised preoperatively by their demographics (age, sex and ethnicity) clinical presentation (blood pressure), number of antihypertensive medications and biochemical tests (potassium, aldosterone, renin, ARR ratio).
Number and type of investigations (CT, MRI, AVS, Metomidate) used to stratify for surgery and the size of the adrenal nodules on cross sectional imaging was recorded. Process of stratification was presented as lateralisation to the left or right reached as a consensus between cross sectional imaging, AVS and nuclear medicine imaging.
Data on post operative surgical outcomes included conversion rate to open adrenalectomy, postoperative complications (Clavien-Dindo)and length of hospital stay.
Postoperative outcomes were assessed within 3 months of surgery (short term) and at least 60 months (long term). Data collected were blood pressure, number of antihypertensive medications, plasma concentration of potassium, aldosterone, renin and ARR ratio. Surgical outcomes were categorised using primary aldosteronism surgical outcome score (PASO) criteria of complete, partial or absent success for both clinical and biochemical cure which reflected remission, improvement or persistence of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults diagnosed with primary aldosteronism and underwent surgical treatment
Key inclusion criteria (2 listed)
- Patient underwent adrenalectomy as a management of primary aldosteronism
- Patient available for short term and long term follow up
Key exclusion criteria (2 listed)
- medically treated patients
- not available for follow up
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 |
|---|---|---|
| Laparoscopic/open adrenalectomy | Procedure or surgery | – |
Primary outcome
Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure
Time frame: 3 months for short term and 5 years for long term
Short- and long-term clinical changes for the following parameter: -Systolic and diastolic blood pressure measured in mmHg
Short- and long-term assessment of clinical improvement in number of antihypertensive medications in participants
Time frame: 3 months for short term and 5 years for long term
Short- and long-term clinical changes for the following parameter: -Number of antihypertensive medications
4 secondary outcomes
Short- and long-term assessment of biochemical improvement in serum potassium level in participants
Time frame: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Aldosterone level in participants
Time frame: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Renin level in participants
Time frame: 3 months for short term and 5 years for long term
Short- and long-term assessment of biochemical improvement in serum Aldosterone/Renin ratio (ARR) (pmol/nmol/L) level in participants
Time frame: 3 months for short term and 5 years for long term
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by University College London Hospitals.
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 2 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure (time frame: 3 months for short term and 5 years for long term). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.