HypertensionPhase 4NCT02122731
Amiloride for Resistant Hypertension
A Phase 4 study testing Amiloride in people with Hypertension and Type 2 Diabetes Mellitus, run by Ib Abildgaard Jacobsen at 4 sites in Denmark.
Trial summary
To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM) Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- What is being tested?
- Amiloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesDenmark
- Study dates
- Nov 2010to Aug 2012
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with resistant hypertension (average daytime BP >130and/or >80 mmHg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (AECi) or angiotensin recpetor blocker (ARBs) and a third optional, all in optimal dosages.
- type 2 diabetes
- prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (NCT01062763)
Who cannot join
- Office blood pressure (BP) >180/110 mmHg
- daytime average BP by ambulatory monitoring > 170/85 mmHg
- heart failure (NYHA III-IV) Cardiac arrythmia HbA1C > 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (eGFR) <50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Sydvestjysk Hospital, Esbjerg
Esbjerg
Sygehus Lillebaelt.
Fredericia
Steno Diabetes Center
Gentofte Municipality
Odense University Hospital, Department of Endocrinology
Odense
About this study
Official title: Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride
To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)
Read the detailed description
The primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study.
The secondary objectives were to evaluate the additional effects of amiloride on:
- Urinary albumin excretion
- Blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment.
- Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric patients in the cohort.
- Urokinase plasminogen activator (uPA) activity
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- Being tested
- Amiloride
- Keywords
- antihypertensive therapy, amiloride, add-on, resistant hypertension, blood pressure control, type 2 diabetes mellitus,, microalbuminuria.
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
5 mg(daily of amiloride was added to patients triple antihypertensive therapy and increased to 10 mg/daily if office blood pressure at 4 weeks was above 130/80 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Experimental | This is a non-randomized and non-controlled study with only one treatment arm with amiloride. Receives: Drug: Amiloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
average daytime systolic and diastolic blood pressure
ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride
Measured: 8 weeks
Secondary outcomes (4)
Urinary albumin excretion
Urine albumin was measured at baseline and after 8 weeks of amiloride treatment.
Measured: after 8 weeks
plasma potassium
plasma potassium tend to increase during amiloride treatment
Measured: after 4 and 8 weeks
urinary urokinase plasminogen activator (uPA) activity
uPA exist in urine where it cleaves plasminogen to plasmin. uPA is possible secreted fra the tubulus cells
Measured: At baseline and after 8 weeks of amiloride treatment
urine plasminogen and plasmin
U-plasminogen is filtered to urine in patients with microalbuminuria. In urine plasminogen is activated to plasmin by urokinase plasminogen activator.Plasmin activates the epithelial sodium channel.
Measured: at baseline and after 8 weeks of amiloride treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ib Abildgaard Jacobsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ib Abildgaard Jacobsen, Odense University Hospital
- Investigators
- Ib A Jacobsen, DMSc, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122731
- Sponsor's protocol ID
- EudraCT 2009-017033
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oxlund CS, Henriksen JE, Tarnow L, Schousboe K, Gram J, Jacobsen IA. Low dose spironolactone reduces blood pressure in patients with resistant hypertension and type 2 diabetes mellitus: a double blind randomized clinical trial. J Hypertens. 2013 Oct;31(10):2094-102. doi: 10.1097/HJH.0b013e3283638b1a.
PubMed 24107738
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride
- ClinicalTrials.gov ID
- NCT02122731
- Acronym / sponsor ID
- EudraCT 2009-017033
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- Keywords
- antihypertensive therapy, amiloride, add-on, resistant hypertension, blood pressure control, type 2 diabetes mellitus,, microalbuminuria.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ib Abildgaard JacobsenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Apr 2014 (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.
To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)
Detailed description
The primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study.
The secondary objectives were to evaluate the additional effects of amiloride on:
- Urinary albumin excretion
- Blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment.
- Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric patients in the cohort.
- Urokinase plasminogen activator (uPA) activity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Experimental | Drug: AmilorideThis is a non-randomized and non-controlled study with only one treatment arm with amiloride. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with resistant hypertension (average daytime BP >130and/or >80 mmHg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (AECi) or angiotensin recpetor blocker (ARBs) and a third optional, all in optimal dosages.
- type 2 diabetes
- prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (NCT01062763)
Key exclusion criteria (3 listed)
- Office blood pressure (BP) >180/110 mmHg
- daytime average BP by ambulatory monitoring > 170/85 mmHg
- heart failure (NYHA III-IV) Cardiac arrythmia HbA1C > 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (eGFR) <50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation
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 |
|---|---|---|
| Amiloride5 mg(daily of amiloride was added to patients triple antihypertensive therapy and increased to 10 mg/daily if office blood pressure at 4 weeks was above 130/80 mmHg. | Drug | Amiloride |
Primary outcome
average daytime systolic and diastolic blood pressure
Time frame: 8 weeks
ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride
4 secondary outcomes
Urinary albumin excretion
Time frame: after 8 weeks
plasma potassium
Time frame: after 4 and 8 weeks
urinary urokinase plasminogen activator (uPA) activity
Time frame: At baseline and after 8 weeks of amiloride treatment
urine plasminogen and plasmin
Time frame: at baseline and after 8 weeks of amiloride treatment
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 24 Apr 2014.
- Background: PubMed 24107738Oxlund CS, Henriksen JE, Tarnow L, Schousboe K, Gram J, Jacobsen IA. Low dose spironolactone reduces blood pressure in patients with resistant hypertension and type 2 diabetes mellitus: a double blind randomized clinical trial. J Hypertens. 2013 Oct;31(10):2094-102. doi: 10.1097/HJH.0b013e3283638b1a.
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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.
Ib A Jacobsen, DMSc principal investigator
Odense University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiloride in people with Hypertension and Type 2 Diabetes Mellitus, run by Ib Abildgaard Jacobsen at 4 sites in Denmark.
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 3 inclusion and 3 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 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
average daytime systolic and diastolic blood pressure (time frame: 8 weeks). 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 NCT02122731, which also lists 1 linked publication.
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 24 Apr 2014.