Primary AldosteronismPA_PACESNCT03174847
Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in 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). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. Read more about this study
- Who is it for?
- Ages 21 to 80 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?
- Adrenalectomy and Mineralocorticoid Receptor Antagonists
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Feb 2017to 20 Sep 2020
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed primary aldosteronism
Who may be able to join
- Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease)
Who cannot join
- Unable to give consent ii. < 21 years or > 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
Majority of patients with hypertension have primary hypertension (without an underlying cause). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. 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). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication.
Read more
It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results.
Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.
- Conditions
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- Being tested
- Adrenalectomy, Mineralocorticoid Receptor Antagonists
- Keywords
- Primary aldosteronism, Blood pressure, Adrenalectomy, Mineralocorticoid-receptor Antagonists, Cardiovascular, Endothelial, Renal
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalectomyProcedure or surgery
Adrenalectomy for unilateral adrenal hyperplasia / adenoma
Mineralocorticoid Receptor AntagonistsDrug
Also called Spironolactone, Eplerenone, Amiloride
Medical treatment with MRA / amiloride
| Study group | Role | What they receive |
|---|---|---|
| Medical Treatment | Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests) Receives: Drug: Mineralocorticoid Receptor Antagonists | |
| Surgical Treatment | Patients with unilateral PA who underwent adrenalectomy Receives: Procedure: Adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure assessed by 24hr ambulatory BP
Measured: Change from Baseline Blood Pressure at 12 months
Secondary outcomes (15)
Use of antihypertension medications
Use of antihypertension medications as expressed in daily defined dosages and total number of medications
Measured: Change from Baseline Antihypertension medications at 12 months
Blood Pressure
Clinic blood pressure
Measured: Change from Baseline Clinic Blood Pressure at 12 months
Cardiac function
Cardiac function using 2DE
Measured: Change from Baseline Cardiac function at 12 months.
Left ventricular hypertrophy
as assessed by 2DE and ECG
Measured: Change from Baseline Left ventricular hypertrophy at 12 months
Renal Function
change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)
Measured: Change from Baseline Renal Function at 12 months
Quality of Life (RAND-36)
RAND-36
Measured: Change from Baseline Quality of Life RAND-36 at 12 months
Quality of Life ( Beck's depression inventory II)
Beck's depression inventory II
Measured: Change from Baseline Quality of Life (BDI-II) at 12 months
Quality of Life (EQ5D)
EQ5D
Measured: Change from Baseline EQ5D at 12 months
Lipids
Lipids
Measured: Change from Baseline Lipids at 12 months
Transaminitis
ALT, AST,
Measured: Change from Baseline transaminitis at 12 months
Insulin Resistance
Measured with HOMA
Measured: Change from Baseline Insulin resistance at 12 months
Fasting glucose
Fasting glucose
Measured: Change from Baseline Fasting glucose at 12 months
weight
change in weight
Measured: Change from Baseline weight at 12 months
Control of hypertension
Proportion of patients reaching normal BP (ambulatory /home BP <135/85 or clinic BP <140/90)
Measured: Change from Baseline Status of hypertension control at 12 months
Cure of Primary aldosteronism
Proportion of patients with cure of PA after adrenalectomy
Measured: Change from Baseline Status of primary aldosteronism at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Feb 2017
- Primary completion20 Oct 2019
- Study completion20 Sep 2020
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
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy Puar, MRCP (UK), Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174847
- Sponsor's protocol ID
- PA_PACES
- Other IDs
- CHF2016.02-P
- Acronym
- PA_PACES
- Status last verified
- May 2022
- First submitted
- 26 May 2017
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puar TH, Cheong CK, Foo RSY, Saffari SE, Tu TM, Chee MR, Zhang M, Ng KS, Wong KM, Wong A, Ng FC, Aw TC, Khoo J, Gani L, King T, Loh WJ, Soh SB, Au V, Tay TL, Tan E, Mae L, Yew J, Tan YK, Tong KL, Lee S, Chai SC. Treatment of Primary Aldosteronism and Reversal of Renin Suppression Improves Left Ventricular Systolic Function. Front Endocrinol (Lausanne). 2022 Jun 30;13:916744. doi: 10.3389/fendo.2022.916744. eCollection 2022.
PubMed 35846272
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT03174847
- Acronym / sponsor ID
- PA_PACES / PA_PACES
- Conditions
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- Keywords
- Primary aldosteronism, Blood pressure, Adrenalectomy, Mineralocorticoid-receptor Antagonists, Cardiovascular, Endothelial, Renal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 5 Jun 2017 (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). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. 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). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication.
It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results.
Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Treatment | – | Drug: Mineralocorticoid Receptor AntagonistsPatients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests) |
| Surgical Treatment | – | Procedure: AdrenalectomyPatients with unilateral PA who underwent adrenalectomy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed primary aldosteronism
Key inclusion criteria (1 listed)
- Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease)
Key exclusion criteria (1 listed)
- Unable to give consent ii. < 21 years or > 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding
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 |
|---|---|---|
| AdrenalectomyAdrenalectomy for unilateral adrenal hyperplasia / adenoma | Procedure or surgery | Surgical Treatment |
| Mineralocorticoid Receptor AntagonistsAlso: Spironolactone, Eplerenone, AmilorideMedical treatment with MRA / amiloride | Drug | Medical Treatment |
Primary outcome
Blood Pressure
Time frame: Change from Baseline Blood Pressure at 12 months
Blood pressure assessed by 24hr ambulatory BP
15 secondary outcomes
Use of antihypertension medications
Time frame: Change from Baseline Antihypertension medications at 12 months
Blood Pressure
Time frame: Change from Baseline Clinic Blood Pressure at 12 months
Cardiac function
Time frame: Change from Baseline Cardiac function at 12 months.
Left ventricular hypertrophy
Time frame: Change from Baseline Left ventricular hypertrophy at 12 months
Renal Function
Time frame: Change from Baseline Renal Function at 12 months
Quality of Life (RAND-36)
Time frame: Change from Baseline Quality of Life RAND-36 at 12 months
Quality of Life ( Beck's depression inventory II)
Time frame: Change from Baseline Quality of Life (BDI-II) at 12 months
Quality of Life (EQ5D)
Time frame: Change from Baseline EQ5D at 12 months
Lipids
Time frame: Change from Baseline Lipids at 12 months
Transaminitis
Time frame: Change from Baseline transaminitis at 12 months
Insulin Resistance
Time frame: Change from Baseline Insulin resistance at 12 months
Fasting glucose
Time frame: Change from Baseline Fasting glucose at 12 months
weight
Time frame: Change from Baseline weight at 12 months
Control of hypertension
Time frame: Change from Baseline Status of hypertension control at 12 months
Cure of Primary aldosteronism
Time frame: Change from Baseline Status of primary aldosteronism at 12 months
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 20 May 2022.
- Derived from this study: PubMed 35846272Puar TH, Cheong CK, Foo RSY, Saffari SE, Tu TM, Chee MR, Zhang M, Ng KS, Wong KM, Wong A, Ng FC, Aw TC, Khoo J, Gani L, King T, Loh WJ, Soh SB, Au V, Tay TL, Tan E, Mae L, Yew J, Tan YK, Tong KL, Lee S, Chai SC. Treatment of Primary Aldosteronism and Reversal of Renin Suppression Improves Left Ventricular Systolic Function. Front Endocrinol (Lausanne). 2022 Jun 30;13:916744. doi: 10.3389/fendo.2022.916744. eCollection 2022.
- 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.
Troy Puar, MRCP (UK) 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: finished, as of the sponsor's last update on 20 May 2022. 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?
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?
Blood Pressure (time frame: Change from Baseline Blood Pressure at 12 months). 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 NCT03174847, 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 20 May 2022.