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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017033-22 | EudraCT Number |
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The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg.
Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| addition of spironolactone | Experimental | spironolactone is added to previous antihypertensive treatment |
|
| Placebo | Placebo Comparator | Addition of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spironolactone | Drug | 25 to 50 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of of Systolic Blood Pressure | Change of systolic blood pressure from baseline to study end at four months. | 4 months |
| Change of Diastolic Blood Pressure | Change of diastolic blood pressure from baseline to study end at four months. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ib A Jacobsen, DMSc | Odense University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11821720 | Background | Elliott HL, Elawad M, Wilkinson R, Singh SP. Persistence of antihypertensive efficacy after missed doses: comparison of amlodipine and nifedipine gastrointestinal therapeutic system. J Hypertens. 2002 Feb;20(2):333-8. doi: 10.1097/00004872-200202000-00025. | |
| 14573330 | Background | Nishizaka MK, Zaman MA, Calhoun DA. Efficacy of low-dose spironolactone in subjects with resistant hypertension. Am J Hypertens. 2003 Nov;16(11 Pt 1):925-30. doi: 10.1016/s0895-7061(03)01032-x. |
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163 patints screened. 44 screenfailures due to exclusion criteria as indicated. 119 randomized
Patients recruited from outpatient clinics of endocrinology at two university hospitals and two general hospitals in the period from May 2010 to March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 1tablet of matching placebo trated up to 2 if neccessary |
| FG001 | Addition of Spironolactone | spironolactone is added to previous antihypertensive treatment placebo : addition of placebo 1 to 2 tablets daily spironolactone : 25 to 50 mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Addition of Spironolactone | spironolactone is added to previous antihypertensive treatment placebo : addition of placebo 1 to 2 tablets daily spironolactone : 25 to 50 mg once daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of of Systolic Blood Pressure | Change of systolic blood pressure from baseline to study end at four months. | Analysis by intention to treat using LOCF | Posted | Mean | 95% Confidence Interval | mm Hg | 4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Addition of Spironolactone | spironolactone is added to previous antihypertensive treatment spironolactone : 25 uptrated if necessary to 50 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment | Plasma potasium above 5.5 mmol/l |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ib A. Jacobsen | Dept. of Endocrinology, Odense University Hospital | +45 27203135 | ib.abildgaard@rsyd.dk |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| C563514 | Hypertension Resistant to Conventional Therapy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| placebo |
| Drug |
addition of placebo 1 to 2 tablets daily |
|
| 16814132 | Background | Sharabi Y, Adler E, Shamis A, Nussinovitch N, Markovitz A, Grossman E. Efficacy of add-on aldosterone receptor blocker in uncontrolled hypertension. Am J Hypertens. 2006 Jul;19(7):750-5. doi: 10.1016/j.amjhyper.2005.11.016. |
| 17309946 | Background | Chapman N, Dobson J, Wilson S, Dahlof B, Sever PS, Wedel H, Poulter NR; Anglo-Scandinavian Cardiac Outcomes Trial Investigators. Effect of spironolactone on blood pressure in subjects with resistant hypertension. Hypertension. 2007 Apr;49(4):839-45. doi: 10.1161/01.HYP.0000259805.18468.8c. Epub 2007 Feb 19. |
| 33107592 | Derived | Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4. |
| 24739800 | Derived | Oxlund CS, Cangemi C, Henriksen JE, Jacobsen IA, Gram J, Schousboe K, Tarnow L, Argraves WS, Rasmussen LM. Low-dose spironolactone reduces plasma fibulin-1 levels in patients with type 2 diabetes and resistant hypertension. J Hum Hypertens. 2015 Jan;29(1):28-32. doi: 10.1038/jhh.2014.27. Epub 2014 Apr 17. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
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| Secondary | Adverse Effects | Intention to treat | Posted | Number | participants | 4 months |
|
|
|
| Primary | Change of Diastolic Blood Pressure | Change of diastolic blood pressure from baseline to study end at four months. | Analyzed by intention to treat and last observation carried forward | Posted | Mean | 95% Confidence Interval | mm Hg | 4 months |
|
|
|
| 1 |
| 61 |
| 0 |
| 61 |
| EG001 | Placebo | 1tablet of matching placebo uptrated to 2 if neccessary | 0 | 58 | 0 | 58 |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |