Hypertension Clinical Trial
— PRIMALOfficial title:
Screening for Primary Aldosteronism in a Population of Patients With Hypertension
Verified date | December 2023 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension. Cardiovascular morbidity and mortality in hypertension rises significantly for patients who have aldosterone overproduction when compared with those with primary hypertension and the same level of blod pressure elevation. The classical signs of PA such as severe hypertension and hypokalemia may be absent, why screening in defined risk groups has been recommended. Screening has not been systematically implemented in Sweden, probably due to expensive, time and effort-consuming clinical routine protocols and low awareness of the problem among clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied adequately, and few studies from Northern Europe have addressed the problem. The primary objective is to investigate prevalence of PA among patients with hypertension in primary care and to implement and assess optimal treatment. Discovered cases of PA will go through routine clinical work-up in order to distinguish the subtype of PA, which includes computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with unilateral disease who are willing and fit for surgery will be offered unilateral minimally invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment, as well as patients with bilateral disease will be offered medical treatment with mineralocorticoid receptor antagonists (MRA). Study participants will be then followed up one year after surgery or initiation of specific medical treatment. Please se outcome measures for relevant description of those. Blood samples will be collected from patients with confirmed PA to be stored in a biobank for potential future genetical and biochemical studies. A subgroup of patients with PA will undergo adrenal-specific positron-emission tomography to assess the possibility to un-invasively diagnose and subtype PA.
Status | Completed |
Enrollment | 1183 |
Est. completion date | November 28, 2023 |
Est. primary completion date | November 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - participants must have Swedish personal number (that gives right to all kinds of necessary planned health care) Exclusion Criteria: - pregnancy |
Country | Name | City | State |
---|---|---|---|
Sweden | Uppsala University, the Department of Surgical Sciences | Uppsala | Uppsla |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Uppsala-Örebro Regional Research Council |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence estimates of primary aldosteronism (PA) and of PA subtypes in a Swedish population of primary care patients with arterial hypertension | ARR - Aldosterone-Renin Ratio; i.v. - intravenous; NaCl - sodium chloride; | For each patient, the time necessary to go through initial (sometimes repeated) screening with ARR, then (sometimes repeated) confirmation testing with i.v. NaCl-suppression test will be approximately 6 months | |
Secondary | The proportion of screening-discovered patients with PA who could be offered surgical treatment - and who have accepted operation and have been unilaterally adrenalectomized. | Percentage - relevant to the number of discovered cases of PA. | Considering work-up time and waiting time for planned surgery of this type it is realistic to assume minimal time frame of approximately 2 years | |
Secondary | Changes in clinical characteristics of hypertension and in antihypertensive treatment regimen still needed - one year after the diagnosis of primary aldosteronism had been stated and specific treatment applied. | Those patients who get the diagnosis of PA after the initial screening and further investigations by the study protocol will be offered specific medical or surgical treatment - depending on the subtype of PA.
In both medically and surgically treated patients the assessment is going to include blood pressure level, usage of MRA and their doses, usage of other antihypertensive medications, their number and doses, frequency of significant side effects of MRA such as gynecomastia, gynecodynia, erectile dysfunction, decreased libido, menstrual disturbances. |
Evaluation of treatment effects is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening. | |
Secondary | Serum potassium level - one year after the diagnosis of primary aldosteronism had been stated and specific treatment applied. | Serum potassium in mmol/l. | Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening. | |
Secondary | Any potassium supplementation if still needed - one year after the diagnosis of primary aldosteronism. | Supplementation measured as "still needed" or "not needed". | Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening. | |
Secondary | Serum creatinine - one year after the diagnosis of primary aldosteronism. | Serum creatinine in mcmol/l. | Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening. | |
Secondary | Control of Aldosterone Renin Ratio (ARR) after the same 2 weeks long preliminary optimization period as at initial ARR screening - one year after surgical treatment for PA. | As plasma aldosterone is measured in pmol/l and plasma Direct Renin Concentration (DRC) in mU/l, ARR is accordingly measured as pmol/mU. The measure of ARR will be evaluated as at the initial ARR screening. | Evaluation is done at the follow-up patient contact one year after adrenal surgery - approximately 2 years after the first screening. | |
Secondary | Postoperative pain characteristics. | Changes from baseline in pain scores on the Visual Analog Scale at postoperative day one and two, and at 1 year postoperatively. | Early postoperative pain scores are recorded during postoperative hospital stay, approximately 1 year after first screening. Late ones are recorded at the one year postoperative follow-up patient contact, approximately 2 years after first screening. | |
Secondary | Duration of hospital stay after adrenalectomy. | Number of days. | Recorded during postoperative hospital stay, approximately 1 year after first screening. | |
Secondary | Time before return to work after adrenalectomy. | Number of days. Applies to working study participants. | Recorded as soon as the patient goes back to work after the operation - latest at one year postoperative follow-up patient contact, approximately 2 years after first screening. | |
Secondary | Occurrence of any surgical complications. | Proportion of operated patients who have had any surgical complications. | Early complications are recorded during postoperative hospital stay, approximately 1 year after first screening. Late ones are recorded at the one year postoperative follow-up patient contact, approximately 2 years after first screening. | |
Secondary | Frequency of conversion from planned laparoscopic adrenalectomy to an open procedure. | Proportion of cases where converting to open procedure was needed. | Recorded during postoperative hospital stay, approximately 1 year after first screening. | |
Secondary | Occurrence of any complications related to Adrenal Vein Sampling (AVS). | Proportion of patients who have underwent AVS and have had any complications. | Early complications are recorded during and on the day after the procedure. Late ones are recorded at the one year follow-up patient contact, approximately 2 years after first screening. |
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