MRA and ARB Treatment in Screening of Primary Aldosteronism (EMIRA)
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ClinicalTrials.gov Identifier: NCT04185857 |
Recruitment Status :
Completed
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
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Condition or disease | Intervention/treatment |
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Primary Aldosteronism Due to Aldosterone Producing Adenoma | Drug: canrenone 50-100 mg orally once a day Drug: olmesartan 10-20 mg orally once a day |

Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Official Title: | Effects of Mineralocorticoid and AT-1 Receptor Antagonism on the Aldosterone-Renin Ratio (ARR) In Primary Aldosteronism Patients (EMIRA Study): Rationale and Design |
Actual Study Start Date : | January 1, 2018 |
Actual Primary Completion Date : | October 1, 2019 |
Actual Study Completion Date : | October 25, 2019 |
Group/Cohort | Intervention/treatment |
---|---|
Patients with primary aldosteronism (PA)
After two biochemical and clinical evaluations under baseline conditions PA patients will be treated with canrenone 50-100 mg orally once a day. After one month of such therapy they will undergo the a clinical and biochemical evaluation (FW1). After, they will continue with a combination therapy with canrenone, plus olmesartan starting with 10 mg a day for oral administration, a dose that can be doubled, if necessary, to achieve normotension. At the end of the second month of the double therapy, patients will undergo a biochemical re-evaluation at the Center of Hypertension (FW2). |
Drug: canrenone 50-100 mg orally once a day
After two biochemical and clinical evaluations under baseline conditions and after pharmacological washout from diuretics, betablockers, ARBs or ACEI (about 4 weeks) and MRAs (abut 6 weeks), PA patients will be treated with canrenone 50-100 mg orally once a day. After 1 or 2 weeks the dose will be doubled if necessary to control BP and serum potassium. Drug: olmesartan 10-20 mg orally once a day After one month of treatment with canrenone the patients will undergo a clinical and biochemical evaluation (FW1) in a manner identical to the two basal evaluations. After, they will continue with a combination therapy with canrenone, at the dose reached, plus olmesartan starting with 10 mg a day for oral administration, a dose that could be doubled, if necessary, to achieve normotension. At the end of the second month of the double therapy, patients will undergo a biochemical re-evaluation at the Center of Hypertension (FW2) with methods identical to those performed in the two baseline evaluations and after one month of canrenone. |
- Aldosterone to renin ratio (ARR) [ Time Frame: one month ]ARR measured as ng/mIU after treatment with canrenone, or olmesartan on top of canrenone
- Serum potassium levels [ Time Frame: one month ]Serum potassium measured as mmol/L after treatment with canrenone, or olmesartan on top of canrenone
- Blood pressure [ Time Frame: one month ]Blood pressure measured as mmol/L after treatment with canrenone, or olmesartan on top of canrenone
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- age 18 - 75 years;
- diagnosis of Aldosterone Producing Adenoma (APA);
- written informed consent.
Exclusion Criteria:
- refusal to participate to the study;
- history of intolerance or allergy to canrenone or ARB.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185857
Italy | |
Department of Medicine - DIMED, University of Padova, Italy | |
Padova, Italy |
Study Director: | Gian Paolo Rossi | University of Padova |
Responsible Party: | Gian Paolo Rossi, MD, FAHA, FACC, Professor, University Hospital Padova |
ClinicalTrials.gov Identifier: | NCT04185857 |
Other Study ID Numbers: |
EMIRA-64140 |
First Posted: | December 4, 2019 Key Record Dates |
Last Update Posted: | December 4, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
renin aldosterone aldosterone to renin ratio |
Adenoma Hyperaldosteronism Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Olmesartan Canrenone Antihypertensive Agents |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |