Arterial HypertensionPhase 3SDHDSNCT01062763

The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension

A Phase 3 study testing spironolactone in people with Arterial Hypertension and Hypertension, Resistant to Conventional Therapy, run by Ib Abildgaard Jacobsen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
What is being tested?: spironolactone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: No sites listed yet
Study dates: Mar 2010to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age < 75 years
Type-2 diabetes
Therapy resistant hypertension (by ABPM)
Treatment with at least 3 antihypertensives

Who cannot join

HbA1c > 10.0
BP > 180/110 mmHg
Secondary hypertension
Intolerance to spironolactone
Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
Total cholesterol 10 mmol/l

Show all 11Show fewer

New York Heart Association class III and IV
Pregnancy or planned pregnancy
Psychiatric disease
Malignant disease
Insufficient adherence

About this study

Official title: South Danish Hypertension and Diabetes Study

The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Read the detailed description

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.

Conditions: Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
Being tested: spironolactone, placebo
Keywords: hypertension, spironolactone, antihypertensive treatment, Type-2 diabetes
Medical subject headings: Hypertension, Hypertension Resistant to Conventional Therapy, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

spironolactoneDrug
25 to 50 mg once daily
placeboDrug
addition of placebo 1 to 2 tablets daily

Study groups in NCT01062763
Study group	Role	What they receive
addition of spironolactone	Experimental	spironolactone is added to previous antihypertensive treatment Receives: Drug: spironolactone
Placebo	Placebo comparator	Addition of placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of of Systolic Blood Pressure
Change of systolic blood pressure from baseline to study end at four months.
Measured: 4 months
Change of Diastolic Blood Pressure
Change of diastolic blood pressure from baseline to study end at four months.
Measured: 4 months

Secondary outcomes (1)

Adverse Effects
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010May 2012

First posted4 Feb 2010 (estimated)
Study startMar 2010
Primary completionMar 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Arterial 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01062763
Sponsor's protocol ID: EudraCT 2009-017033-22
Other IDs: 2009-017033-22, 2009
Acronym: SDHDS
Status last verified: Apr 2014
First submitted: 3 Feb 2010
Last updated: 8 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 11821720
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.
PubMed 14573330
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.
PubMed 16814132
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.
PubMed 17309946
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.
PubMed 33107592
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.
PubMed 24739800

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: South Danish Hypertension and Diabetes Study
ClinicalTrials.gov ID: NCT01062763
Acronym / sponsor ID: SDHDS / EudraCT 2009-017033-22
Conditions: Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
Keywords: hypertension, spironolactone, antihypertensive treatment, Type-2 diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Ib Abildgaard JacobsenUniversity, hospital or other
Study start: Mar 2010
Primary completion: Mar 2012 (actual)
Study completion: May 2012 (actual)
First posted: 4 Feb 2010 (estimated)
Results: Posted 8 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
addition of spironolactone	Experimental	Drug: spironolactonespironolactone is added to previous antihypertensive treatment
Placebo	Placebo comparator	Drug: placeboAddition of placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age < 75 years
Type-2 diabetes
Therapy resistant hypertension (by ABPM)
Treatment with at least 3 antihypertensives

Key exclusion criteria (11 listed)

HbA1c > 10.0
BP > 180/110 mmHg
Secondary hypertension
Intolerance to spironolactone
Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids

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
spironolactone25 to 50 mg once daily	Drug	addition of spironolactone
placeboaddition of placebo 1 to 2 tablets daily	Drug	Placebo

Primary outcome

Change of of Systolic Blood Pressure
Time frame: 4 months
Change of systolic blood pressure from baseline to study end at four months.
Change of Diastolic Blood Pressure
Time frame: 4 months
Change of diastolic blood pressure from baseline to study end at four months.

1 secondary outcome

Adverse Effects
Time frame: 4 months

Results and safety

Results posted to the registry on 8 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	58	55
Addition of Spironolactone	61	57

Primary outcome: Change of of Systolic Blood Pressure

Time frame: 4 months. Mean (95% Confidence Interval). Unit: mm Hg

Measure	Addition of Spironolactone n = 57	Placebo n = 55
Value	-9.6 (-12.8 to -6.3)	-0.7 (-3.3 to 2.0)

Population analysed: Analysis by intention to treat using LOCF

Primary outcome: Change of Diastolic Blood Pressure

Time frame: 4 months. Mean (95% Confidence Interval). Unit: mm Hg

Measure	Addition of Spironolactone n = 57	Placebo n = 55
Value	-3.9 (-6.0 to -2.0)	-0.3 (-1.8 to 1.3)

Population analysed: Analyzed by intention to treat and last observation carried forward

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Addition of Spironolactone	1 of 61 (1.6%)	0 of 61 (0%)	Not reported
Placebo	0 of 58 (0%)	0 of 58 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11821720Elliott 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.
Background: PubMed 14573330Nishizaka 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.
Background: PubMed 16814132Sharabi 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.
Background: PubMed 17309946Chapman 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.
Derived from this study: PubMed 33107592Chung 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.
Derived from this study: PubMed 24739800Oxlund 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.

Related trials for Arterial Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing spironolactone in people with Arterial Hypertension and Hypertension, Resistant to Conventional Therapy, run by Ib Abildgaard Jacobsen.

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 4 inclusion and 11 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change of of Systolic Blood Pressure (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT01062763, 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 8 May 2014.