Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening for Primary Aldosteronism in a Population of Patients With Hypertension (PRIMAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105531
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Per Hellman, Uppsala University

Brief Summary:

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.


Condition or disease
Primary Aldosteronism Hypertension Hypertension Secondary

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Primary Aldosteronism in a Population of Patients With Hypertension
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence estimates of primary aldosteronism (PA) and of PA subtypes in a Swedish population of primary care patients with arterial hypertension [ Time Frame: 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 ]
    ARR - Aldosterone-Renin Ratio; i.v. - intravenous; NaCl - sodium chloride;


Secondary Outcome Measures :
  1. The proportion of screening-discovered patients with PA who could be offered surgical treatment - and who have accepted operation and have been unilaterally adrenalectomized. [ Time Frame: 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 ]
    Percentage - relevant to the number of discovered cases of PA.

  2. 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. [ Time Frame: 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. ]

    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.


  3. Serum potassium level - one year after the diagnosis of primary aldosteronism had been stated and specific treatment applied. [ Time Frame: 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. ]
    Serum potassium in mmol/l.

  4. Any potassium supplementation if still needed - one year after the diagnosis of primary aldosteronism. [ Time Frame: 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. ]
    Supplementation measured as "still needed" or "not needed".

  5. Serum creatinine - one year after the diagnosis of primary aldosteronism. [ Time Frame: 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. ]
    Serum creatinine in mcmol/l.

  6. 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. [ Time Frame: Evaluation is done at the follow-up patient contact one year after adrenal surgery - approximately 2 years after the first screening. ]
    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.

  7. Postoperative pain characteristics. [ Time Frame: 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. ]
    Changes from baseline in pain scores on the Visual Analog Scale at postoperative day one and two, and at 1 year postoperatively.

  8. Duration of hospital stay after adrenalectomy. [ Time Frame: Recorded during postoperative hospital stay, approximately 1 year after first screening. ]
    Number of days.

  9. Time before return to work after adrenalectomy. [ Time Frame: 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. ]
    Number of days. Applies to working study participants.

  10. Occurrence of any surgical complications. [ Time Frame: 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. ]
    Proportion of operated patients who have had any surgical complications.

  11. Frequency of conversion from planned laparoscopic adrenalectomy to an open procedure. [ Time Frame: Recorded during postoperative hospital stay, approximately 1 year after first screening. ]
    Proportion of cases where converting to open procedure was needed.

  12. Occurrence of any complications related to Adrenal Vein Sampling (AVS). [ Time Frame: 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. ]
    Proportion of patients who have underwent AVS and have had any complications.


Biospecimen Retention:   Samples With DNA
Blood samples from patients with documented primary aldosteronism are going to be (with the patients informed conscent) obtained to be stored in Uppsala Biobank for future scientific purposes.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An unselected population of primary care patients with hypertension
Criteria

Inclusion Criteria:

  • participants must have Swedish personal number (that gives right to all kinds of necessary planned health care)

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105531


Contacts
Layout table for location contacts
Contact: Nikita Makhnov 46737390196 nmakhnov@gmail.com
Contact: Per Hellman, PhD 46186114617 per.hellman@surcsci.uu.se

Locations
Layout table for location information
Sweden
Uppsala University, the Department of Surgical Sciences Recruiting
Uppsala, Uppsla, Sweden, 75236
Contact: Nikita Makhnov    46737390196    nmakhnov@gmail.com   
Contact: Per Hellman, PhD    46186114617    per.hellman@surgsci.uu.se   
Sponsors and Collaborators
Uppsala University
Uppsala-Örebro Regional Research Council
Investigators
Layout table for investigator information
Principal Investigator: Per Hellman, PhD Uppsala University, The Department of Surgical Sciences

Layout table for additonal information
Responsible Party: Per Hellman, Professor, Head of the Department of Surgical Sciences, Uppsala University, Uppsala University
ClinicalTrials.gov Identifier: NCT03105531     History of Changes
Other Study ID Numbers: Project 16-25
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Hellman, Uppsala University:
primary aldosteronism
hypertension
screening
secondary hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases