HyperaldosteronismPhase 3SPARTACUSNCT01096654
SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan.
A Phase 3 study testing Ct-scan or adrenal vein sampling in people with Hyperaldosteronism, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands causes hypertension that is often refractory to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperaldosteronism
- What is being tested?
- Ct-scan or adrenal vein sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Jul 2015
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legally capacitated;
- ≥ 18 years of age;
- Diagnosed with hypertension that is difficult to treat (blood pressure > 140/90 mmHg in spite of two antihypertensive drugs in adequate doses), or accompanied by hypokalemia, either spontaneous or induced by use of diuretics;
- patients must have a positive result on a sodium loading test (as recommended in the Endocrine Society Guideline), i.e. insufficient suppression of aldosterone.
- Cooperating patient who is willing to undergo adrenal surgery in case of an adenoma or lateralized aldosterone secretion, who is able to comply with the study protocol and who is willing to give written informed consent.
Who cannot join
- Unsuitability for or objection to undergo AVS, CT or adrenal surgery.(including pregnancy);
- Glucocorticoid remediable aldosteronism or adrenal carcinoma;
- Severe or terminal co-morbidity which seriously interferes with possible treatment or health related quality of life;
- Requirement of certain medication that interacts with the prescribed treatments in this protocol or that can cause hypertension as an important side-effect e.g. glucocorticoids. Patients will only be excluded as the medication cannot be stopped or altered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Cost-effective Management of Patients With Hypertension Due to Primary Aldosteronism: Adrenal Vein Sampling or Ct-scan?
Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands causes hypertension that is often refractory to treatment. PA is usually caused by either a unilateral aldosterone-producing (micro)adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former is treated with the aim of cure by adrenalectomy, and the latter by mineralocorticoid receptor antagonists. This distinction can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline or by CT-scanning, as is common practice in the Netherlands. AVS is invasive, demands great skill, and is expensive, while CT-scanning is non-invasive, easy and cheap, but might be less accurate. However, the advantage of AVS has never been demonstrated in prospective randomized studies. Here we propose to perform a prospective, randomized, multicenter study that compares effectiveness of AVS with effectiveness of CT-scanning for the diagnosis of PA subtype.
Objective: To assess the quantity of antihypertensive medication needed in order to normalize blood pressure in patients who have been managed for PA according to either AVS or CT-scan. Secondary objectives: to assess potassium, costs of management and quality of life.
Read more
Study design: Prospective, randomized trial in a multi-centre setting. Two hundred patients will be recruited within two years. Follow-up will be one year after (start of) treatment.
Study population: Adult patients with therapy-resistant hypertension, with or without hypokalemia, caused by PA.
Intervention: Patients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.
Main study parameters/endpoints: The quantity of antihypertensive drugs patients are using to obtain target blood pressure, expressed in Daily Defined Dosages, is used as the main study parameter. There is no criterion standard for accuracy of the diagnosis of PA-subtype, but we assume that if treatment is based on a more accurate diagnosis, treatment is more effective. The most important secondary endpoints are the costs of the diagnostic course and long-term medical treatment and the quality of life as assessed by a validated questionnaire.
- Conditions
- Hyperaldosteronism
- Being tested
- Ct-scan or adrenal vein sampling
- Keywords
- endocrine hypertension, primary hyperaldosteronism, aldosterone, aldosterone-producing adenoma, bilateral adrenal hyperplasia, computed tomography, adrenal vein sampling
- Medical subject headings
- Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ct-scan or adrenal vein samplingOther
Patients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| CT-scan | Active comparator | In this group treatment will be based on the outcome of the CT-scan only. Patients will be treated by adrenalectomy (Adx) if an unilateral lesion is visible on the CT-scan and the contralateral gland is normal. If bilateral lesions, bilateral enlargement or symmetric normal adrenal glands are present patients will be treated by the mineralocorticoid receptor antagonist (MRA) Receives: Other: Ct-scan or adrenal vein sampling |
| Adrenal Vein Sampling | Active comparator | This group will be treated according to the results of the adrenal vein sampling only. Adrenal vein sampling will be performed under the continuous infusion of ACTH (adrenocorticotropic hormone). A cortisol ratio ≥ 3 between the adrenal vein and the inferior vena cava is set as the criterium for successful cannulation. The criterium for lateralization is a aldosterone/cortisol ratio ≥ 4 between the adrenal veins and a lower aldosterone/cortisol ratio in the contralateral adrenal vein than in the inferior vena cava.
If AVS fails patients will be treated according to the CT-findings as described in the group with CT-scan only. Patients with a successful AVS will be treated by Adrenalectomy if unilateral production of aldosterone is shown. If no unilateral aldosterone production is present, i.e. the aldosterone/cortisol ratio is less than 4, patients will be treated by MRA. Receives: Other: Ct-scan or adrenal vein sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Defined Doses of antihypertensive medication
The main study parameter is the quantity of antihypertensive drugs patients are using to obtain target blood pressure, expressed in Daily Defined Doses (DDD)16. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It provides a fixed unit of measurement independent of price and dosage form (e.g. tablet strength) enabling the researcher to assess trends in drug consumption and to perform comparisons between population groups.
Measured: assessed after 1 year of follow-up
Secondary outcomes (5)
Total cost of diagnosis and management
Costs of the diagnostic course and the first year of treatment after determination of subtype of PA will be calculated prospectively and bottom-up for each participant. This includes costs of CT, AVS (hardware, rent of facility, lab determinations, cost of personnel), operation, outpatient clinic visits, medication and lab controls for potassium and creatinine. Long term costs will be extrapolated from the first year's results for an average life expectancy and a predefined discounting rate.
Measured: assessed after 1 year follow-up
Health Related Quality of Life
The quality of life in our patients may be influenced in different ways. AVS is more invasive and more burdensome to the patient than CT; the same holds for surgery as compared to medical treatment; on the other hand, more intense and prolonged (lifelong) antihypertensive drug treatment may be associated with more side effects. We suggested to explore these issues, using the . EQ-5D (European Quality of Life-5 Dimensions) and the SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey). This will allow for a detailed analysis of the impact of the two strategies on the quality of life of the patients.
Measured: assesed before treatment, at 6 months and at 12 months follow-up
Potassium level
Serum potassium levels will be determined before Adx or start of MRA and one year later. Potassium levels will be compared between the two arms of the study.
Measured: assesed before treatment and after 1 year follow-up
Result of a sodium loading test
This test, which is the reference test for the existence of PA, will be performed only in patients that have undergone adrenalectomy because in these patients PA is expected to be cured after adrenalectomy with hence a normal result of this test. The test will be performed 1 year after operation after interruption of medication that interferes with the measurement of aldosterone levels. The proportion of patients who were cured (i.e. with normal saline loading test) will be compared between the CT- and the AVS-group.
Measured: assessed after 1 year follow-up
Post-hoc analysis: medication dosage
A post-hoc analysis on medication use will be performed using different outcome measures. Required antihypertensive medication one year after the (start of) treatment, expressed in multiples of the recommended starting dose and fraction of the recommended maximum dose, will be analysed.
Measured: assessed after 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Deinum, Dr., Principal investigator, UCM St. Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096654
- Sponsor's protocol ID
- avs-ct1
- Acronym
- SPARTACUS
- Status last verified
- Jul 2015
- First submitted
- 30 Mar 2010
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kempers MJ, Lenders JW, van Outheusden L, van der Wilt GJ, Schultze Kool LJ, Hermus AR, Deinum J. Systematic review: diagnostic procedures to differentiate unilateral from bilateral adrenal abnormality in primary aldosteronism. Ann Intern Med. 2009 Sep 1;151(5):329-37. doi: 10.7326/0003-4819-151-5-200909010-00007.
PubMed 19721021Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1.
PubMed 20124107Kline GA, Harvey A, Jones C, Hill MH, So B, Scott-Douglas N, Pasieka JL. Adrenal vein sampling may not be a gold-standard diagnostic test in primary aldosteronism: final diagnosis depends upon which interpretation rule is used. Variable interpretation of adrenal vein sampling. Int Urol Nephrol. 2008;40(4):1035-43. doi: 10.1007/s11255-008-9441-9. Epub 2008 Aug 12.
PubMed 18696249Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21. No abstract available.
PubMed 19769616Velema M, Dekkers T, Hermus A, Timmers H, Lenders J, Groenewoud H, Schultze Kool L, Langenhuijsen J, Prejbisz A, van der Wilt GJ, Deinum J; SPARTACUS investigators. Quality of Life in Primary Aldosteronism: A Comparative Effectiveness Study of Adrenalectomy and Medical Treatment. J Clin Endocrinol Metab. 2018 Jan 1;103(1):16-24. doi: 10.1210/jc.2017-01442.
PubMed 29099925Dekkers T, Prejbisz A, Kool LJS, Groenewoud HJMM, Velema M, Spiering W, Kolodziejczyk-Kruk S, Arntz M, Kadziela J, Langenhuijsen JF, Kerstens MN, van den Meiracker AH, van den Born BJ, Sweep FCGJ, Hermus ARMM, Januszewicz A, Ligthart-Naber AF, Makai P, van der Wilt GJ, Lenders JWM, Deinum J; SPARTACUS Investigators. Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):739-746. doi: 10.1016/S2213-8587(16)30100-0. Epub 2016 Jun 17.
PubMed 27325147
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Cost-effective Management of Patients With Hypertension Due to Primary Aldosteronism: Adrenal Vein Sampling or Ct-scan?
- ClinicalTrials.gov ID
- NCT01096654
- Acronym / sponsor ID
- SPARTACUS / avs-ct1
- Conditions
- Hyperaldosteronism
- Keywords
- endocrine hypertension, primary hyperaldosteronism, aldosterone, aldosterone-producing adenoma, bilateral adrenal hyperplasia, computed tomography, adrenal vein sampling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Mar 2010 (estimated)
- 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.
Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands causes hypertension that is often refractory to treatment. PA is usually caused by either a unilateral aldosterone-producing (micro)adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former is treated with the aim of cure by adrenalectomy, and the latter by mineralocorticoid receptor antagonists. This distinction can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline or by CT-scanning, as is common practice in the Netherlands. AVS is invasive, demands great skill, and is expensive, while CT-scanning is non-invasive, easy and cheap, but might be less accurate. However, the advantage of AVS has never been demonstrated in prospective randomized studies. Here we propose to perform a prospective, randomized, multicenter study that compares effectiveness of AVS with effectiveness of CT-scanning for the diagnosis of PA subtype.
Objective: To assess the quantity of antihypertensive medication needed in order to normalize blood pressure in patients who have been managed for PA according to either AVS or CT-scan. Secondary objectives: to assess potassium, costs of management and quality of life.
Study design: Prospective, randomized trial in a multi-centre setting. Two hundred patients will be recruited within two years. Follow-up will be one year after (start of) treatment.
Study population: Adult patients with therapy-resistant hypertension, with or without hypokalemia, caused by PA.
Intervention: Patients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.
Main study parameters/endpoints: The quantity of antihypertensive drugs patients are using to obtain target blood pressure, expressed in Daily Defined Dosages, is used as the main study parameter. There is no criterion standard for accuracy of the diagnosis of PA-subtype, but we assume that if treatment is based on a more accurate diagnosis, treatment is more effective. The most important secondary endpoints are the costs of the diagnostic course and long-term medical treatment and the quality of life as assessed by a validated questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-scan | Active comparator | Other: Ct-scan or adrenal vein samplingIn this group treatment will be based on the outcome of the CT-scan only. Patients will be treated by adrenalectomy (Adx) if an unilateral lesion is visible on the CT-scan and the contralateral gland is normal. If bilateral lesions, bilateral enlargement or symmetric normal adrenal glands are present patients will be treated by the mineralocorticoid receptor antagonist (MRA) |
| Adrenal Vein Sampling | Active comparator | Other: Ct-scan or adrenal vein samplingThis group will be treated according to the results of the adrenal vein sampling only. Adrenal vein sampling will be performed under the continuous infusion of ACTH (adrenocorticotropic hormone). A cortisol ratio ≥ 3 between the adrenal vein and the inferior vena cava is set as the criterium for successful cannulation. The criterium for lateralization is a aldosterone/cortisol ratio ≥ 4 between the adrenal veins and a lower aldosterone/cortisol ratio in the contralateral adrenal vein than in the inferior vena cava. If AVS fails patients will be treated according to the CT-findings as described in the group with CT-scan only. Patients with a successful AVS will be treated by Adrenalectomy if unilateral production of aldosterone is shown. If no unilateral aldosterone production is present, i.e. the aldosterone/cortisol ratio is less than 4, patients will be treated by MRA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Legally capacitated;
- ≥ 18 years of age;
- Diagnosed with hypertension that is difficult to treat (blood pressure > 140/90 mmHg in spite of two antihypertensive drugs in adequate doses), or accompanied by hypokalemia, either spontaneous or induced by use of diuretics;
- patients must have a positive result on a sodium loading test (as recommended in the Endocrine Society Guideline), i.e. insufficient suppression of aldosterone.
- Cooperating patient who is willing to undergo adrenal surgery in case of an adenoma or lateralized aldosterone secretion, who is able to comply with the study protocol and who is willing to give written informed consent.
Key exclusion criteria (4 listed)
- Unsuitability for or objection to undergo AVS, CT or adrenal surgery.(including pregnancy);
- Glucocorticoid remediable aldosteronism or adrenal carcinoma;
- Severe or terminal co-morbidity which seriously interferes with possible treatment or health related quality of life;
- Requirement of certain medication that interacts with the prescribed treatments in this protocol or that can cause hypertension as an important side-effect e.g. glucocorticoids. Patients will only be excluded as the medication cannot be stopped or altered.
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 |
|---|---|---|
| Ct-scan or adrenal vein samplingPatients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia. | Other | Adrenal Vein Sampling, CT-scan |
Primary outcome
Daily Defined Doses of antihypertensive medication
Time frame: assessed after 1 year of follow-up
The main study parameter is the quantity of antihypertensive drugs patients are using to obtain target blood pressure, expressed in Daily Defined Doses (DDD)16. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It provides a fixed unit of measurement independent of price and dosage form (e.g. tablet strength) enabling the researcher to assess trends in drug consumption and to perform comparisons between population groups.
5 secondary outcomes
Total cost of diagnosis and management
Time frame: assessed after 1 year follow-up
Health Related Quality of Life
Time frame: assesed before treatment, at 6 months and at 12 months follow-up
Potassium level
Time frame: assesed before treatment and after 1 year follow-up
Result of a sodium loading test
Time frame: assessed after 1 year follow-up
Post-hoc analysis: medication dosage
Time frame: assessed after 1 year follow-up
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 Jul 2015.
- Background: PubMed 19721021Kempers MJ, Lenders JW, van Outheusden L, van der Wilt GJ, Schultze Kool LJ, Hermus AR, Deinum J. Systematic review: diagnostic procedures to differentiate unilateral from bilateral adrenal abnormality in primary aldosteronism. Ann Intern Med. 2009 Sep 1;151(5):329-37. doi: 10.7326/0003-4819-151-5-200909010-00007.
- Background: PubMed 20124107Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1.
- Background: PubMed 18696249Kline GA, Harvey A, Jones C, Hill MH, So B, Scott-Douglas N, Pasieka JL. Adrenal vein sampling may not be a gold-standard diagnostic test in primary aldosteronism: final diagnosis depends upon which interpretation rule is used. Variable interpretation of adrenal vein sampling. Int Urol Nephrol. 2008;40(4):1035-43. doi: 10.1007/s11255-008-9441-9. Epub 2008 Aug 12.
- Background: PubMed 19769616Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21. No abstract available.
- Derived from this study: PubMed 29099925Velema M, Dekkers T, Hermus A, Timmers H, Lenders J, Groenewoud H, Schultze Kool L, Langenhuijsen J, Prejbisz A, van der Wilt GJ, Deinum J; SPARTACUS investigators. Quality of Life in Primary Aldosteronism: A Comparative Effectiveness Study of Adrenalectomy and Medical Treatment. J Clin Endocrinol Metab. 2018 Jan 1;103(1):16-24. doi: 10.1210/jc.2017-01442.
- Derived from this study: PubMed 27325147Dekkers T, Prejbisz A, Kool LJS, Groenewoud HJMM, Velema M, Spiering W, Kolodziejczyk-Kruk S, Arntz M, Kadziela J, Langenhuijsen JF, Kerstens MN, van den Meiracker AH, van den Born BJ, Sweep FCGJ, Hermus ARMM, Januszewicz A, Ligthart-Naber AF, Makai P, van der Wilt GJ, Lenders JWM, Deinum J; SPARTACUS Investigators. Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):739-746. doi: 10.1016/S2213-8587(16)30100-0. Epub 2016 Jun 17.
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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.
Jacob Deinum, Dr. principal investigator
UCM St. Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ct-scan or adrenal vein sampling in people with Hyperaldosteronism, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 4 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 Jul 2015. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Daily Defined Doses of antihypertensive medication (time frame: assessed after 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096654, which also lists 6 linked publications.
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 Jul 2015.