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| Name | Class |
|---|---|
| University of Yaounde 1 | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Spironolactone | Experimental | Add-on low dose 25 mg Spironolactone to current hypertension treatment |
|
| Routine | Active Comparator | Routine intensification of anti hypertensive treatment based on existing guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose spironolactone | Drug | 4-week add-on low dose spironolactone in resistant hypertension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Blood pressure reduction) | Blood pressure reduction | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Potassium (Change in serum potassium) | Change in serum potassium | 4 weeks |
| Creatinine (Change in serum creatinine) | Change in serum creatinine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Mbanya, MD, PhD | University of Yaounde 1 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Obesity Centre, Yaounde Central Hospital | Yaoundé | Centre Region | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27007793 | Derived | 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. |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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| Routine intensification of antihypertensive treatment | Other | 4-week guidelines oriented intensification of antihypertensive treatment |
|
| 4 weeks |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |