Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery (ALDOPARA2)

January 27, 2026 updated by: NOMINE-CRIQUI Claire, Central Hospital, Nancy, France

Aldosterone Variations in Patients With Primary Hyperparathyroidism Before Surgery and in the Year Following Surgery for Parathyroid Disease.

Primary hyperparathyroidism is a disorder of calcium and phosphorus metabolism linked to dysfunction of one or more parathyroid glands. The latest recommendations from the American Association of Endocrine Surgeons (7) consider the presence of hypertension as an argument for proposing the removal of a parathyroid adenoma in the context of primary hyperparathyroidism. The renin-angiotensin-aldosterone system is involved in regulating blood pressure.

The main objective of this study is to assess aldosterone level in patients with primary hyperparathyroidism before surgery and its variation in the year following surgery for parathyroid disease.

Secondary objectives are to assess aldosterone variations after surgery at 3 months

  • Assess aldosterone variations after surgery at 6 months
  • Assess aldosterone variations after surgery at 12 months
  • Blood pressure changes before and after surgery (5 pre- and post-operative measurements)
  • Assess the number of antihypertensive treatments before and after surgery

  • Assess antihypertensive treatment according to the WHO-DDD classification before and after surgery Compare aldosterone levels in the 'primary hyperparathyroidism' group with a control group of patients from the general population (using the STANISLAS cohort).

    • Compare aldosterone levels in the HPT group with aldosterone levels in a group of patients after myocardial infarction (cardiovascular patient group )

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Primary hyperparathyroidism is a disorder of calcium and phosphorus metabolism linked to dysfunction of one or more parathyroid glands, without any underlying chronic kidney disease. The disease manifests itself in its classic forms as elevated blood calcium, parathyroid hormone and calcium levels. It has an impact on bone mineralisation, the presence of kidney stones, glucose metabolism (1)(2) and cardiovascular function (3)(4)(5).

A Scottish study published in 2023, based on a robust medical information system enabling prospective follow-up, showed an overall prevalence of primary hyperparathyroidism between 2007 and 2018 of 0.84%, which was much higher in women (1.18%) than in men (0.48%) (6) The latest recommendations from the American Association of Endocrine Surgeons (7) consider the presence of hypertension as an argument for proposing the removal of a parathyroid adenoma in the context of primary hyperparathyroidism: 'Parathyroidectomy may be offered to surgical candidates with cardiovascular disease who might benefit from mitigation of potential cardiovascular sequelae other than hypertension.' There appears to be an association between hypertension and primary hyperparathyroidism (4)(5). Its mechanism is currently poorly understood and little described. Using the keywords 'hyperaldosteronism' AND 'hyperparathyroidism', we found only one case report (in Spanish) and one article, but these focused more on patients already suffering from primary hyperaldosteronism (8)(9).

The renin-angiotensin-aldosterone system is involved in regulating blood pressure.

This is why we systematically measure aldosterone and renin preoperatively and at three postoperative points following surgery for primary hyperparathyroidism.

This is a retrospective study including among 400 patients with primary hyperparathyroidism. Allt his patients underwent parathyroidectomy.

Inclusion critera : patients with primary hyperparathyroidism, age>18 years Exclusion criteria : patients with hyperparathyroidism and renal insuffisency Pregant women, patients < 18 years. All patients underwent blood tests including PTH, calcium, aldosterone and renin levels before surgery and 3 months, 6 months and 12 months after surgery.

The number and type of antihypertensive treatments were systematically recorded before and 3 months after surgery.

In a second step, the aldosterone levels of patients with primary hyperparathyroidism will be compared with a cohort of patients from the general population: the STNISLAS cohort, and with a cohort of patients with cardiovascular disease. This will enable to identify whether aldosterone levels in the population of patients with primary hyperparathyroidism differ from those in the general population.

The Main objective is to assess the role of phosphorus-calcium metabolism on the renin-angiotensin system in patients with primary hyperparathyroidism (PHPT)

The Secondary objectives are :

  1. To describe the evolution of the renin-angiotensin system (plasma aldosterone and renin levels) before and after parathyroidectomy (at 3, 6 and 12 months) in patients with PHPT.
  2. To evaluate the links between changes in phosphorus-calcium metabolism and variations in plasma aldosterone and renin levels after surgery for PHPT.
  3. To evaluate changes in the number and dosage (WHO-DDD classification) of antihypertensive medications before and after surgery for PHPT.
  4. To evaluate changes in blood pressure values before and after surgery for PHPT (five measurements).
  5. To evaluate the links between blood pressure values before and after surgery for PHPT and changes in plasma aldosterone and renin levels.
  6. To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus healthy patients from the general population (STANISLAS cohort)

8) To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus patients with cardiovascular disease (REMI cohort)

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Centre hospitalier universitaire de NANCY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with primary hyperparathyroidism, without renal insufficiency , candidate to parathyroid surgery

Description

Inclusion Criteria:

  • patients with primary hyperparathyroidism candidate to surgery
  • age>/=18 years

Exclusion Criteria:

age< 18 years patients with renal insufficiency (CKDEpi <60ml/mn) pregant women

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with primary hyperparathyroidism

Patients with primary hyperparathyroidism who are candidates for surgery. All patients underwent biological testing for parathyroid hormone, calcium, aldosterone, renin and renal function.

Their blood pressure was measured five times during the pre-operative consultation and after surgery.

Their antihypertensive treatments were collected prior to surgery and after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldosteron variation before and after surgery
Time Frame: from enrollment to 12 months after surgery
Variation of aldosteron level between the time before surgery and after surgery at 3 points : 3,6 and 12 months after surgery
from enrollment to 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Parathormon levels
Time Frame: 3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
Preoperative and postoperative Plasma parathormone levels
3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
Plasma Calcium and Phosphorus levels
Time Frame: 3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
Preoperative and postoperative Plasma calcium and phosphorus levels
3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
Plasma renin levels
Time Frame: 3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
Preoperative and postoperative Plasma renin levels
3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery
type and number of antihypertensive medications
Time Frame: from 3 months before surgery to 3 months after
Preoperative and postoperative type and number of antihypertensive medications : the number, the type and the dosage of anti-hypertensive drugs is collected before and 3 months after surgery
from 3 months before surgery to 3 months after
WHO_DDD classification
Time Frame: from 3 months before surgery to 3 months after
Using the WHO_DDD classification , a score of anti-hypertensive medication is calculated before and after surgery for each patient.
from 3 months before surgery to 3 months after
Systolic and diastolic blood pressure (SBP and DBP)
Time Frame: from 3 months before surgery to 3 months after
Preoperative and postoperative SBP and DBP value in mmHg are systematically measured 3 months before and 3 months after surgery.
from 3 months before surgery to 3 months after
Preoperative glomerular filtration rate (GFR)
Time Frame: 3 months before surgery.
Preoperative glomerular filtration rate (GFR) is measured before surgery. Patients with renal insufficiency are excluded.
3 months before surgery.
Preoperative 25 OH vitD
Time Frame: 3 months before surgery
Plasma of 25OH vitamin D before surgery
3 months before surgery
Preoperative 24h calciuria
Time Frame: 3 months before surgery
24h calciuria 3 months before surgery
3 months before surgery
Kidney stones
Time Frame: 3 months before surgery
Presence of kidney stones on ultrasound or abdominal CT scan prior to parathyroid surgery
3 months before surgery
femoral T score
Time Frame: 3 months before surgery
Femoral T-score on preoperative bone densitometry
3 months before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026PI016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hyperparathyroidism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe