Resistant HypertensionPrePAReNCT04213963
Prospective Study on Primary Aldosteronism in Resistant Hypertension
An observational study of Resistant Hypertension and Primary Aldosteronism, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resistant Hypertension, Primary Aldosteronism, Refractory Hypertension
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2011to 31 Oct 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At least 100 consecutive patients with age over 18 and under 80 years old and resistant hypertension (defined as uncontrolled blood pressure despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic) referred to the center for diagnosis and treatment of Hypertension (Division of Endocrinology, Diabetology and Metabolism, University of Turin) between March 2011 and July 2020.
Who may be able to join
- age over 18 and under 80 years old;
- diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.
Who cannot join
- age under 18 or over 80 years old;
- pseudo-resistant hypertension (poor medication adherence, high salt intake);
- previous cardiovascular disease;
- insulin treated diabetes mellitus;
- other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
- liver cirrhosis;
Show all 13Show fewer
- chronic heart failure;
- known malignant neoplasm;
- chronic disease with major organ involvement;
- excessive alcohol ingestion;
- current steroids assumption;
- use of sympathomimetic drugs;
- use of contraceptives.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Division of Endocrinology, Diabetology and Metabolism; University of Turin
Turin, Piedmont, 10126
Mauro M Maccario, MD, 00390116709559, mauro.maccario@unito.it
Mirko M Parasiliti Caprino, MD, PhD, 00390116335544/5527, mirko.parasiliticaprino@unito.it
About this study
Official title: Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.
Read the detailed description
PA is the most frequent form of secondary hypertension, with a prevalence that increases with the severity of hypertension. The wide variation of the reported PA prevalence is due to different study design and population. Very few data derive from well designed prospective study. Additional problems in the interpretation of study results are the different diagnostic cut-off used in various centers and the low diffusion of the adrenal vein sampling, that has a central role in the PA diagnosis.
Resistant hypertension (RH) is a condition of insufficient BP control, despite appropriate lifestyle measures and treatment with at least 3 drugs at full dose, including a diuretic, in patients whose adherence to therapy has been confirmed. The primary aim of our study is define prospectively the prevalence of PA in RH.
Moreover, emerging evidence supports the crucial role of elevated serum aldosterone in promoting cardiovascular disease, independently from high BP levels. Aldosterone improves oxidative stress, inflammation, impairs insulin metabolic signaling, reduced endothelial-mediated vasorelaxation and is associated to cardiovascular and renal abnormalities. However, current data on the contribution of PA on cardiometabolic complications have heterogeneous results.
The secondary outcome of our study is to investigate prospectively the association of PA with cardiometabolic complications in a cohort of patients with RH.
- Conditions
- Resistant Hypertension, Primary Aldosteronism, Refractory Hypertension, Hypertensive End-Organ Damage, Atrial Fibrillation, Aortic Ectasia
- Keywords
- Resistant Hypertension, Primary Aldosteronism, Renin-Angiotensin System, Blood Pressure, Cardiometabolic Risk, Early Atherosclerotic Damage, Oxidative Stress
- Medical subject headings
- Hyperaldosteronism, Hypertension, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Basal Aldosterone (pg/mL) at baseline.
Measured: Baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Basal Plasma Renin Activity (PRA, ng/mL/h) at baseline.
Measured: Baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Aldosterone (pg/mL) post saline infusion test, performed at baseline.
Measured: Baseline.
Secondary outcomes (18)
Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension
Left ventricular mass evaluation with Echocardiogram at baseline.
Measured: Baseline.
Microalbuminuria in primary aldosteronism and essential resistant hypertension.
Albuminuria/Creatininuria ratio (mg/mmoL) at baseline.
Measured: Baseline.
Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.
Intima media thickness values (mm) evaluation with carotid Doppler ultrasound at baseline.
Measured: Baseline
Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.
Serum creatinine (mg/dL) at baseline.
Measured: Baseline.
Aortic ectasia in primary aldosteronism versus essential resistant hypertension.
Aortic size (mm) determined with echocardiogram at baseline.
Measured: Baseline.
Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.
Electrocardiogram (ECG) at baseline.
Measured: Baseline.
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.
Measured: Baseline
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of insulin (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.
Measured: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0' and 120' at baseline.
Measured: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
HbA1c (mmol/mol) at baseline.
Measured: Baseline.
Sodium levels in primary aldosteronism versus essential resistant hypertension.
Serum Sodium (mmol/L) at baseline.
Measured: Baseline.
Potassium levels in primary aldosteronism versus essential resistant hypertension.
Serum Potassium (mmol/L) at baseline.
Measured: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Blood determination of 8-isoprostane (UI/L) at baseline.
Measured: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Blood determination of total antioxidant capacity (UI/L) at baseline.
Measured: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum triglycerides (mg/dL) at baseline.
Measured: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum total-Cholesterol (mg/dL) at baseline.
Measured: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum HDL-Cholesterol (mg/dL) at baseline.
Measured: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum LDL-Cholesterol (mg/dL) at baseline.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Sep 2011
- Primary completion30 Sep 2020
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Resistant 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Maccario, University of Turin, Italy
- Investigators
- Mauro M Maccario, MD, Principal investigator, Endocrinology, Diabetology and Metabolism; University of TurinEzio E Ghigo, MD, Study chair, Endocrinology, Diabetology and Metabolism; University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213963
- Sponsor's protocol ID
- The PrePARe Study
- Acronym
- PrePARe
- Status last verified
- Nov 2020
- First submitted
- 19 Dec 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
PubMed 26934393Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
PubMed 28385310Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.
PubMed 17161262Mulatero P, Stowasser M, Loh KC, Fardella CE, Gordon RD, Mosso L, Gomez-Sanchez CE, Veglio F, Young WF Jr. Increased diagnosis of primary aldosteronism, including surgically correctable forms, in centers from five continents. J Clin Endocrinol Metab. 2004 Mar;89(3):1045-50. doi: 10.1210/jc.2003-031337.
PubMed 15001583Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension. 2002 Dec;40(6):892-6. doi: 10.1161/01.hyp.0000040261.30455.b6.
PubMed 12468575Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens. 2003 May;17(5):349-52. doi: 10.1038/sj.jhh.1001554.
PubMed 12756408Eide IK, Torjesen PA, Drolsum A, Babovic A, Lilledahl NP. Low-renin status in therapy-resistant hypertension: a clue to efficient treatment. J Hypertens. 2004 Nov;22(11):2217-26. doi: 10.1097/00004872-200411000-00026.
PubMed 15480108Chandran P. Resistant or difficult-to-control hypertension. N Engl J Med. 2006 Nov 2;355(18):1934; author reply 1934. doi: 10.1056/NEJMc062276. No abstract available.
PubMed 17079772Schmidt BM, Schmieder RE. Aldosterone-induced cardiac damage: focus on blood pressure independent effects. Am J Hypertens. 2003 Jan;16(1):80-6. doi: 10.1016/s0895-7061(02)03199-0.
PubMed 12517689Fallo F, Veglio F, Bertello C, Sonino N, Della Mea P, Ermani M, Rabbia F, Federspil G, Mulatero P. Prevalence and characteristics of the metabolic syndrome in primary aldosteronism. J Clin Endocrinol Metab. 2006 Feb;91(2):454-9. doi: 10.1210/jc.2005-1733. Epub 2005 Nov 15.
PubMed 16291704Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7.
PubMed 18314347Whaley-Connell A, Johnson MS, Sowers JR. Aldosterone: role in the cardiometabolic syndrome and resistant hypertension. Prog Cardiovasc Dis. 2010 Mar-Apr;52(5):401-9. doi: 10.1016/j.pcad.2009.12.004.
PubMed 20226958Fiebeler A, Luft FC. The mineralocorticoid receptor and oxidative stress. Heart Fail Rev. 2005 Jan;10(1):47-52. doi: 10.1007/s10741-005-2348-y.
PubMed 15947891Vogt B, Burnier M. Aldosterone and cardiovascular risk. Curr Hypertens Rep. 2009 Dec;11(6):450-5. doi: 10.1007/s11906-009-0076-8.
PubMed 19895757Morrow JD. Quantification of isoprostanes as indices of oxidant stress and the risk of atherosclerosis in humans. Arterioscler Thromb Vasc Biol. 2005 Feb;25(2):279-86. doi: 10.1161/01.ATV.0000152605.64964.c0. Epub 2004 Dec 9.
PubMed 15591226
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
- ClinicalTrials.gov ID
- NCT04213963
- Acronym / sponsor ID
- PrePARe / The PrePARe Study
- Conditions
- Resistant Hypertension, Primary Aldosteronism, Refractory Hypertension, Hypertensive End-Organ Damage, Atrial Fibrillation, Aortic Ectasia
- Keywords
- Resistant Hypertension, Primary Aldosteronism, Renin-Angiotensin System, Blood Pressure, Cardiometabolic Risk, Early Atherosclerotic Damage, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Dec 2019 (actual)
- 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.
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.
Detailed description
PA is the most frequent form of secondary hypertension, with a prevalence that increases with the severity of hypertension. The wide variation of the reported PA prevalence is due to different study design and population. Very few data derive from well designed prospective study. Additional problems in the interpretation of study results are the different diagnostic cut-off used in various centers and the low diffusion of the adrenal vein sampling, that has a central role in the PA diagnosis.
Resistant hypertension (RH) is a condition of insufficient BP control, despite appropriate lifestyle measures and treatment with at least 3 drugs at full dose, including a diuretic, in patients whose adherence to therapy has been confirmed. The primary aim of our study is define prospectively the prevalence of PA in RH.
Moreover, emerging evidence supports the crucial role of elevated serum aldosterone in promoting cardiovascular disease, independently from high BP levels. Aldosterone improves oxidative stress, inflammation, impairs insulin metabolic signaling, reduced endothelial-mediated vasorelaxation and is associated to cardiovascular and renal abnormalities. However, current data on the contribution of PA on cardiometabolic complications have heterogeneous results.
The secondary outcome of our study is to investigate prospectively the association of PA with cardiometabolic complications in a cohort of patients with RH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 100 consecutive patients with age over 18 and under 80 years old and resistant hypertension (defined as uncontrolled blood pressure despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic) referred to the center for diagnosis and treatment of Hypertension (Division of Endocrinology, Diabetology and Metabolism, University of Turin) between March 2011 and July 2020.
Key inclusion criteria (2 listed)
- age over 18 and under 80 years old;
- diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.
Key exclusion criteria (13 listed)
- age under 18 or over 80 years old;
- pseudo-resistant hypertension (poor medication adherence, high salt intake);
- previous cardiovascular disease;
- insulin treated diabetes mellitus;
- other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Time frame: Baseline.
Basal Aldosterone (pg/mL) at baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Time frame: Baseline.
Basal Plasma Renin Activity (PRA, ng/mL/h) at baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Time frame: Baseline.
Aldosterone (pg/mL) post saline infusion test, performed at baseline.
18 secondary outcomes
Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension
Time frame: Baseline.
Microalbuminuria in primary aldosteronism and essential resistant hypertension.
Time frame: Baseline.
Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline
Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Aortic ectasia in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Sodium levels in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Potassium levels in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Results publication: PubMed 26934393Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Results publication: PubMed 28385310Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
- Results publication: PubMed 17161262Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.
- Results publication: PubMed 15001583Mulatero P, Stowasser M, Loh KC, Fardella CE, Gordon RD, Mosso L, Gomez-Sanchez CE, Veglio F, Young WF Jr. Increased diagnosis of primary aldosteronism, including surgically correctable forms, in centers from five continents. J Clin Endocrinol Metab. 2004 Mar;89(3):1045-50. doi: 10.1210/jc.2003-031337.
- Results publication: PubMed 12468575Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension. 2002 Dec;40(6):892-6. doi: 10.1161/01.hyp.0000040261.30455.b6.
- Results publication: PubMed 12756408Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens. 2003 May;17(5):349-52. doi: 10.1038/sj.jhh.1001554.
- Results publication: PubMed 15480108Eide IK, Torjesen PA, Drolsum A, Babovic A, Lilledahl NP. Low-renin status in therapy-resistant hypertension: a clue to efficient treatment. J Hypertens. 2004 Nov;22(11):2217-26. doi: 10.1097/00004872-200411000-00026.
- Results publication: PubMed 17079772Chandran P. Resistant or difficult-to-control hypertension. N Engl J Med. 2006 Nov 2;355(18):1934; author reply 1934. doi: 10.1056/NEJMc062276. No abstract available.
- Results publication: PubMed 12517689Schmidt BM, Schmieder RE. Aldosterone-induced cardiac damage: focus on blood pressure independent effects. Am J Hypertens. 2003 Jan;16(1):80-6. doi: 10.1016/s0895-7061(02)03199-0.
- Results publication: PubMed 16291704Fallo F, Veglio F, Bertello C, Sonino N, Della Mea P, Ermani M, Rabbia F, Federspil G, Mulatero P. Prevalence and characteristics of the metabolic syndrome in primary aldosteronism. J Clin Endocrinol Metab. 2006 Feb;91(2):454-9. doi: 10.1210/jc.2005-1733. Epub 2005 Nov 15.
- Results publication: PubMed 18314347Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7.
- Results publication: PubMed 20226958Whaley-Connell A, Johnson MS, Sowers JR. Aldosterone: role in the cardiometabolic syndrome and resistant hypertension. Prog Cardiovasc Dis. 2010 Mar-Apr;52(5):401-9. doi: 10.1016/j.pcad.2009.12.004.
- Individual participant dataSharing planned: No
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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.
Mauro M Maccario, MD principal investigator
Endocrinology, Diabetology and Metabolism; University of Turin
Ezio E Ghigo, MD study chair
Endocrinology, Diabetology and Metabolism; University of Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension and Primary Aldosteronism, run by University of Turin, Italy at 1 site in Italy.
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 13 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: status not confirmed, as of the sponsor's last update on 3 Nov 2020. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro M Maccario, MD (00390116709559, mauro.maccario@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. (time frame: Baseline.). The study lists 3 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 NCT04213963, which also lists 24 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 3 Nov 2020.