Hypertension, Resistant to Conventional TherapyPhase 4SPIRYNCT02426099
Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
A Phase 4 study testing Low dose spironolactone and Routine intensification of antihypertensive treatment in people with Hypertension, Resistant to Conventional Therapy and Diabetes Mellitus, run by Sobngwi Eugene at 1 site in Cameroon.
Trial summary
This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
- What is being tested?
- Low dose spironolactone and Routine intensification of antihypertensive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCameroon
- Study dates
- Oct 2011to Oct 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant hypertension
- Diabetes mellitus
Who cannot join
- T2DM with overt acute/chronic complications,
- serum potassium ≥ 5.5 mmol/l,
- estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet in Renal Disease formula ≤ 30 ml/min/1.73m² of body weight,
- absolute contraindication to any of the drug regimen of the trial,
- and current aldosterone antagonist treatment or cessation within the last 15 months
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
National Obesity Centre, Yaounde Central Hospital
Yaoundé, Centre Region
About this study
Official title: Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde
This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive regimen , all added to previous regimen with unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four following add-on therapy initiation. The primary outcome is change in office and self-measurement blood pressure recorded at each visit, and secondary outcomes are variations in serum potassium, sodium, and creatinine levels.
- Being tested
- Low dose spironolactone, Routine intensification of antihypertensive treatment
- Keywords
- Resistant hypertension, diabetes mellitus, Spironolactone, African
- Medical subject headings
- 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.
Low dose spironolactoneDrug
Also called Aldactone
4-week add-on low dose spironolactone in resistant hypertension
Routine intensification of antihypertensive treatmentOther
4-week guidelines oriented intensification of antihypertensive treatment
| Study group | Role | What they receive |
|---|---|---|
| Low dose Spironolactone | Experimental | Add-on low dose 25 mg Spironolactone to current hypertension treatment Receives: Drug: Low dose spironolactone |
| Routine | Active comparator | Routine intensification of anti hypertensive treatment based on existing guidelines Receives: Other: Routine intensification of antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Blood pressure reduction)
Blood pressure reduction
Measured: 4 weeks
Secondary outcomes (2)
Potassium (Change in serum potassium)
Change in serum potassium
Measured: 4 weeks
Creatinine (Change in serum creatinine)
Change in serum creatinine
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 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 Hypertension, Resistant to Conventional TherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sobngwi Eugene
- Sponsor type
- Other government
- Collaborators
- University of Yaounde 1
- Responsible party
- Sponsor-investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Jean-Claude Mbanya, MD, PhD, Study chair, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426099
- Sponsor's protocol ID
- CNO22011
- Acronym
- SPIRY
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Djoumessi RN, Noubiap JJ, Kaze FF, Essouma M, Menanga AP, Kengne AP, Mbanya JC, Sobngwi E. Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population. BMC Res Notes. 2016 Mar 23;9:187. doi: 10.1186/s13104-016-1987-5.
PubMed 27007793
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde
- ClinicalTrials.gov ID
- NCT02426099
- Acronym / sponsor ID
- SPIRY / CNO22011
- Keywords
- Resistant hypertension, diabetes mellitus, Spironolactone, African
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sobngwi EugeneOther government
- Collaborators
- University of Yaounde 1
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Apr 2015 (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.
This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive regimen , all added to previous regimen with unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four following add-on therapy initiation. The primary outcome is change in office and self-measurement blood pressure recorded at each visit, and secondary outcomes are variations in serum potassium, sodium, and creatinine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Spironolactone | Experimental | Drug: Low dose spironolactoneAdd-on low dose 25 mg Spironolactone to current hypertension treatment |
| Routine | Active comparator | Other: Routine intensification of antihypertensive treatmentRoutine intensification of anti hypertensive treatment based on existing guidelines |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resistant hypertension
- Diabetes mellitus
Key exclusion criteria (5 listed)
- T2DM with overt acute/chronic complications,
- serum potassium ≥ 5.5 mmol/l,
- estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet in Renal Disease formula ≤ 30 ml/min/1.73m² of body weight,
- absolute contraindication to any of the drug regimen of the trial,
- and current aldosterone antagonist treatment or cessation within the last 15 months
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 |
|---|---|---|
| Low dose spironolactoneAlso: Aldactone4-week add-on low dose spironolactone in resistant hypertension | Drug | Low dose Spironolactone |
| Routine intensification of antihypertensive treatment4-week guidelines oriented intensification of antihypertensive treatment | Other | Routine |
Primary outcome
Efficacy (Blood pressure reduction)
Time frame: 4 weeks
Blood pressure reduction
2 secondary outcomes
Potassium (Change in serum potassium)
Time frame: 4 weeks
Creatinine (Change in serum creatinine)
Time frame: 4 weeks
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 2015.
- Derived from this study: PubMed 27007793Djoumessi RN, Noubiap JJ, Kaze FF, Essouma M, Menanga AP, Kengne AP, Mbanya JC, Sobngwi E. Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population. BMC Res Notes. 2016 Mar 23;9:187. doi: 10.1186/s13104-016-1987-5.
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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.
Jean-Claude Mbanya, MD, PhD study chair
University of Yaounde 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose spironolactone and Routine intensification of antihypertensive treatment in people with Hypertension, Resistant to Conventional Therapy and Diabetes Mellitus, run by Sobngwi Eugene at 1 site in Cameroon.
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 2 inclusion and 5 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 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 Cameroon. 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?
Efficacy (Blood pressure reduction) (time frame: 4 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 NCT02426099, 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 2015.