Primary AldosteronismPA_OutcomeNCT04428827
Outcome of Patients With Primary Aldosteronism
An observational study of Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- What is being tested?
- Unilateral adrenalectomy in patients with unilateral disease
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2016to 30 Jul 2022
- 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 14 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with suspected primary aldosteronism managed at referral centre for suspected primary aldosteronism
Who may be able to join
- Patients with suspected primary aldosteronism
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Troy Puar, 67888833, troy_puar@cgh.com.sg
About this study
Official title: Long-term Outcomes in Patients With Primary Aldosteronism After Treatment
Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands).
It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to increased cardiovascular morbidity and mortality. This is supported by studies showing reversal of these effects after treatment for PA.
The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients with PA, compared to patients with essential hypertension.
- Conditions
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), Adrenalectomy; Status, Mineralocorticoid Excess, Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use
- Being tested
- Unilateral adrenalectomy in patients with unilateral disease
- Medical subject headings
- Hyperaldosteronism, Renal Insufficiency, Chronic, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral adrenalectomy in patients with unilateral diseaseProcedure or surgery
Unilateral adrenalectomy in patients with unilateral disease
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Patients treated with surgery Receives: Procedure: Unilateral adrenalectomy in patients with unilateral disease | |
| Medications | Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in systolic blood pressure before and after treatment
change in systolic blood pressure
Measured: six months after treatment
Secondary outcomes (8)
change in diastolic blood pressure before and after treatment
change in diastolic blood pressure
Measured: six months after treatment
change in systolic blood pressure before and after treatment
change in systolic blood pressure
Measured: through study completion, an average of 5 years
change in diastolic blood pressure before and after treatment
change in diastolic blood pressure
Measured: through study completion, an average of 5 years
cardiovascular outcome
incidence of new cardiovascular events including acute myocardial infarction, revascularisation percutaneously, coronary artery bypass graft, stroke, admission for congestive cardiac failure, atrial fibrillation
Measured: through study completion, an average of 5 years
chronic kidney disease
incidence of worsening chronic kidney disease, decline of glomerular filtration rate by 15ml/min from at least 60m/min
Measured: through study completion, an average of 5 years
Renal Progression
rate of decline of glomerular filtration rate
Measured: through study completion, an average of 5 years
variables that predict unilateral disease
Identify variables that are more common in patients with unilateral disease
Measured: through study completion, an average of 5 years
variables that predict blood pressure response
Identify variables that are more common in patients with positive blood pressure response
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Oct 2016
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Troy Puar, MRCP, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428827
- Sponsor's protocol ID
- PA_Outcome
- Acronym
- PA_Outcome
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2020
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of anonymised pooled data
Publications
Puar TH, Loh LM, Loh WJ, Lim DST, Zhang M, Tan PT, Lee L, Swee DS, Khoo J, Tay D, Tan SY, Zhu L, Gani L, King TF, Kek PC, Foo RS. Outcomes in unilateral primary aldosteronism after surgical or medical therapy. Clin Endocrinol (Oxf). 2021 Feb;94(2):158-167. doi: 10.1111/cen.14351. Epub 2020 Oct 26.
PubMed 33058182
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes in Patients With Primary Aldosteronism After Treatment
- ClinicalTrials.gov ID
- NCT04428827
- Acronym / sponsor ID
- PA_Outcome / PA_Outcome
- Conditions
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), Adrenalectomy; Status, Mineralocorticoid Excess, Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 11 Jun 2020 (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.
Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands).
It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to increased cardiovascular morbidity and mortality. This is supported by studies showing reversal of these effects after treatment for PA.
The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients with PA, compared to patients with essential hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: Unilateral adrenalectomy in patients with unilateral diseasePatients treated with surgery |
| Medications | – | –Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected primary aldosteronism managed at referral centre for suspected primary aldosteronism
Key inclusion criteria (1 listed)
- Patients with suspected primary aldosteronism
Key exclusion criteria (1 listed)
- Nil
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 adrenalectomy in patients with unilateral diseaseUnilateral adrenalectomy in patients with unilateral disease | Procedure or surgery | Surgery |
Primary outcome
change in systolic blood pressure before and after treatment
Time frame: six months after treatment
change in systolic blood pressure
8 secondary outcomes
change in diastolic blood pressure before and after treatment
Time frame: six months after treatment
change in systolic blood pressure before and after treatment
Time frame: through study completion, an average of 5 years
change in diastolic blood pressure before and after treatment
Time frame: through study completion, an average of 5 years
cardiovascular outcome
Time frame: through study completion, an average of 5 years
chronic kidney disease
Time frame: through study completion, an average of 5 years
Renal Progression
Time frame: through study completion, an average of 5 years
variables that predict unilateral disease
Time frame: through study completion, an average of 5 years
variables that predict blood pressure response
Time frame: through study completion, an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 33058182Puar TH, Loh LM, Loh WJ, Lim DST, Zhang M, Tan PT, Lee L, Swee DS, Khoo J, Tay D, Tan SY, Zhu L, Gani L, King TF, Kek PC, Foo RS. Outcomes in unilateral primary aldosteronism after surgical or medical therapy. Clin Endocrinol (Oxf). 2021 Feb;94(2):158-167. doi: 10.1111/cen.14351. Epub 2020 Oct 26.
- Individual participant dataSharing planned: Undecided. Sharing of anonymised pooled data
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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.
Troy Puar, MRCP principal investigator
Changi General Hospital
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 and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Changi General Hospital at 1 site in Singapore.
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 1 inclusion and 1 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 12 Aug 2021. 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 Singapore. 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 Troy Puar, MRCP (67888833, troy_puar@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in systolic blood pressure before and after treatment (time frame: six months after treatment). 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 NCT04428827, which also lists 1 linked publication.
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 12 Aug 2021.