Adrenalectomy; StatusHyperaldoNCT03648294
Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism
An observational study of Adrenalectomy; Status, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated. Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Adrenalectomy; Status
- What is being tested?
- adrenalectomy for primary addosteronism
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2013to 31 Jan 2017
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between 2002 and 2013, the investigators evaluated all patients receiving adrenalectomy and extracted data on PAH patients. The diagnosis was made on the presence of hypertension (all stages combined), an autonomous hyperproduction of aldosterone and sometimes hypokalemia (n = 32). HTA was defined, in accordance with the recommendations of the Haute Autorité de Santé and the French Society of Arterial Hypertension (blood pressure greater than or equal to 140/90 mmHg)
Who may be able to join
- Patients >25 years and <80 years patients undergoing adrenalectomy for PA
- All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI).
Who cannot join
- patients <25 years
- patients > 80 years
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.
Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).
Read the detailed description
To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).
- Conditions
- Adrenalectomy; Status
- Being tested
- adrenalectomy for primary addosteronism
- Keywords
- blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenalectomy for primary addosteronismOther
All of the clinical and biological data were retrospectively compiled from the patient computerized record. The variables analyzed were: age, sex, body mass index (BMI), PAH discovery circumstances, pre- and postoperative systolic and diastolic blood pressure assessments, number of pre-hypertensive antihypertensive drug - and postoperatively, the laterality, the size and nature of the lesions, the operating time, the surgical technique used. The biological data evaluated were pre- and postoperative plasma and plasma creatinine, preoperative serum aldosterone concentrations, plasma renin activity, and preoperative aldosterone / renin ratio. Hypokalemia was defined as serum concentration below 3.5 mmol / L.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenalectomy for primary hyperaldosteronism
The objective of this study is to evaluate the course of the disease associated with long-term outcomes of adrenalectomy for the treatment of PAH, with a retrospective analysis of patient data!
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Dec 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenalectomy; StatusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Saint, MD, PhD, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648294
- Sponsor's protocol ID
- PI2017_843_0040
- Acronym
- Hyperaldo
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism
- ClinicalTrials.gov ID
- NCT03648294
- Acronym / sponsor ID
- Hyperaldo / PI2017_843_0040
- Conditions
- Adrenalectomy; Status
- Keywords
- blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 27 Aug 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.
To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.
Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).
Detailed description
To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between 2002 and 2013, the investigators evaluated all patients receiving adrenalectomy and extracted data on PAH patients. The diagnosis was made on the presence of hypertension (all stages combined), an autonomous hyperproduction of aldosterone and sometimes hypokalemia (n = 32). HTA was defined, in accordance with the recommendations of the Haute Autorité de Santé and the French Society of Arterial Hypertension (blood pressure greater than or equal to 140/90 mmHg)
Key inclusion criteria (2 listed)
- Patients >25 years and <80 years patients undergoing adrenalectomy for PA
- All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI).
Key exclusion criteria (2 listed)
- patients <25 years
- patients > 80 years
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 |
|---|---|---|
| adrenalectomy for primary addosteronismAll of the clinical and biological data were retrospectively compiled from the patient computerized record. The variables analyzed were: age, sex, body mass index (BMI), PAH discovery circumstances, pre- and postoperative systolic and diastolic blood pressure assessments, number of pre-hypertensive antihypertensive drug - and postoperatively, the laterality, the size and nature of the lesions, the operating time, the surgical technique used. The biological data evaluated were pre- and postoperative plasma and plasma creatinine, preoperative serum aldosterone concentrations, plasma renin activity, and preoperative aldosterone / renin ratio. Hypokalemia was defined as serum concentration below 3.5 mmol / L. | Other | – |
Primary outcome
Adrenalectomy for primary hyperaldosteronism
Time frame: 1 year
The objective of this study is to evaluate the course of the disease associated with long-term outcomes of adrenalectomy for the treatment of PAH, with a retrospective analysis of patient data!
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 16 Jun 2026.
- 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.
Fabien Saint, MD, PhD principal investigator
CHU AMIENS
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 Adrenalectomy; Status, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 16 Jun 2026. 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 France. 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?
Adrenalectomy for primary hyperaldosteronism (time frame: 1 year). 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 16 Jun 2026.