Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCentral Hospital, Nancy, France
About this trial
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 )
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with primary hyperparathyroidism candidate to surgery
age>/=18 years
Disqualifiers
None
Trial population
Patients with primary hyperparathyroidism, without renal insufficiency , candidate to parathyroid surgery
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Patients with primary hyperparathyroidism
Trial outcomes
Primary outcomes
1
Aldosteron variation before and after surgery
Variation of aldosteron level between the time before surgery and after surgery at 3 points : 3,6 and 12 months after surgery
Time frame
from enrollment to 12 months after surgerySecondary outcomes
1
Plasma Parathormon levels
Preoperative and postoperative Plasma parathormone levels
Time frame
3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery2
Plasma Calcium and Phosphorus levels
Preoperative and postoperative 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 surgery3
Plasma renin levels
Preoperative and postoperative 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 surgery4
type and number of antihypertensive medications
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
Time frame
from 3 months before surgery to 3 months afterSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: