HypertensionPhase 4HEBRONCT03476616

Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients

A Phase 4 study testing Eplerenone (-based therapy) arm and Valsartan (-based therapy) arm in people with Hypertension and Obesity, run by Hippocration General Hospital at 1 site in Greece.

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

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Hypertension, Obesity
What is being tested?: Eplerenone (-based therapy) arm and Valsartan (-based therapy) arm
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 1 siteGreece
Study dates: 1 Sep 2018to 30 Jun 2025
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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

30-75 years of age
Written consent
Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg, confirmed by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg
Obesity, confirmed estimated by Body Mass Index (BMI) of 30-40 kg/m2

Who cannot join

Age <30 or >75
Inability to give informed consent
Participation in a clinical study involving an investigational drug or device within 4 weeks of screening
Secondary hypertension
Recent (<6 months) cardiovascular event requiring hospitalization (eg. myocardial infarction or stroke)
Type 1 diabetes

Show all 29Show fewer

Chronic kidney disease assessed by Estimated Glomerular Filtration Rate (eGFR) <45 mL/min
Bilateral renal arteries stenosis
Addison's disease
Hemodynamically significant valvular heart disease
Plasma potassium outside of normal range on two successive measurements during screening
Pregnancy, planning to conceive or women of childbearing potential, that is, not using effective contraception
Scheduled surgery or cardiovascular surgery over the next 6 months
Absolute contra-indication to study drugs (eg. asthma) or previous intolerance of trial therapy
History of sustained atrial fibrillation
Requirement for study drug for reason other than to treat hypertension, (eg, β-blockers for angina or aldosterone antagonists for heart failure)
Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy)
Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or
severely limit that patients' life-span or ability to complete the study (eg, alcohol or drug abuse, disabling or terminal illness, mental
disorders)
Contemporary systemic disease with life expectancy shorter than the end of the study
Treatment with any of the following medications:
Oral corticosteroids within 3 months of screening. Treatment with systemic corticosteroids is also prohibited during study participation
Chronic stable use, or unstable use of NSAIDs (other than low dose aspirin) is prohibited. Chronic use is defined as >3 consecutive or non-consecutive days of treatment per week. In addition, intermittent use of NSAIDs is strongly discouraged throughout the study and NSAIDs if required, must not be used for more than a total of 2 days. For those requiring analgesics during the study, paracetamol is recommended.
The use of short-acting nitrates (eg, sublingual nitroglycerin) is permitted.
The use of sympathomimetic decongestants is permitted, however, not within 1 day prior to any study visit/BP assessment
The use of theophylline is permitted but the dose must be stable for at least 4 weeks prior to screening and throughout the study;
The use of phosphodiesterase type V inhibitors is permitted; however, study participants must refrain from taking these medications for at least 1 day prior to screening or any subsequent study visits
The use of α-blockers is not permitted, with the exception of alfuzosin and tamsulosin for prostatic symptoms

Trial locations and contacts

1 site in 1 country.

Greece1 site

Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Athens, Greece
Athens, Athens, 11527

Other trials in Greece

About this study

Official title: Hypertension thErapy With irBesartan Versus EpleRenone for Obese Patients: A Randomized Clinical Trial

Obesity is a complex metabolic state at which many pathophysiological pathways seem to interfere, like imbalance of autonomic nervous system, as well as renin-angiotensin-aldosterone system (RAAS) activation. Latest studies have shown that the increase of peripheral fat in obese patients, alongside with the increase of P-450 aromatase leads to hyper-aldosteronism, which results to increased sodium intake and rise of blood pressure. The present study aims to investigate the potential superiority of an aldosterone antagonist based therapy (eplerenone) over the renin-angiotensin antagonists (ARBs) (valsartan) based therapy in hypertensive obese patients regarding reduction of blood pressure (office, home and ambulatory) over a 24-week period.

Read the detailed description

The present study plans to enroll obese patients (BMI= 30-40 kg/m2) of 30-75 years of age, with untreated or never-treated essential hypertension to either eplerenone-based or irbesartan-based therapy Patients visiting hypertension center(s), eligible to participate in the study and meeting study's inclusion criteria, will at first thoroughly be informed of study's protocol rationale, including scheduled follow-up visits. There will be a period of 2-4 weeks, at which medical history will be taken, as well as somatometrics, including height, weight, BMI and waist circumference. Moreover, a thorough clinical examination will take place, including office blood pressure, ECG, heart-echo, renal ultrasound, blood and urine ultrasound. All women of gestational age should have pregnancy test.

At randomization visit, patients still meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or irbesartan (I) 150mg od for 8 weeks. At 8, 16 and 24 weeks, patients at both arms will be evaluated with ambulatory BP measurements primary, as well as home and office BP measurements. At week 8, patients with controlled blood pressure (mean ambulatory blood pressure measurement (ABPM) <130/80mmHg), will continue in monotherapy with eplerenone or irbesartan and patients with uncontrolled hypertension (mean 24-h ambulatory≥130/80mmHg) will continue with the addition of calcium-channel blocker, amlodipine (C) 5 mg od. At week 16, patients achieving BP control will continue in either monotherapy (E), (I) or dual therapy (E+C), (I+C). However, in patients not achieving blood pressure target, a third drug, thiazide-like-diuretic will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be finally evaluated at 24 weeks.

Conditions: Hypertension, Obesity
Being tested: Eplerenone (-based therapy) arm, Valsartan (-based therapy) arm
Keywords: Hypertension, Obesity, Ambulatory Blood Pressure, Eplerenone, Valsartan, Mineralocorticoid Receptor Antagonists, Angiotensin II Receptor Blockers
Medical subject headings: Hypertension, Obesity

What participants receive

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

Eplerenone (-based therapy) armDrug
At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.
Valsartan (-based therapy) armDrug
At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.

Study groups in NCT03476616
Study group	Role	What they receive
Eplerenone (-based therapy) arm	Active comparator	Obese pts with hypertension, starting treatment with eplerenone 25mg twice daily (BD). ABPM wil be scheduled at wks 8, 16 and 24. At wk 8 if mean ABPM < 130/80mm Hg will continue to monotherapy with eplerenone. If not controlled (mean ABPM > 130/80mm Hg) at wk8, amlodipine 5mg OD will be added. At wk 16 if mean ABPM < 130/80mm Hg will continue to monotherapy with eplerenone, or dual therapy with eplerenone and amlodipine. If not controlled (mean ABPM > 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks. Receives: Drug: Eplerenone (-based therapy) arm
Irbesartan (-based therapy) arm	Active comparator	Obese pts with hypertension, starting treatment with irbesartan 150mg once daily (OD). ABPM wil be scheduled at wks 8, 16 and 24. At wk 8 if mean ABPM < 130/80mm Hg will continue to monotherapy with irbesartan. If not controlled (mean ABPM > 130/80mm Hg) at wk8, amlodipine 5mg OD will be added. At wk 16 if mean ABPM < 130/80mm Hg will continue to monotherapy with irbesartan, or dual therapy with irbesartan and amlodipine. If not controlled (mean ABPM > 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks. Receives: Drug: Valsartan (-based therapy) arm

What is being measured

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

Difference in change of ABPM from baseline, in the eplerenone arm versus the irbesartan arm as monotherapy at 8 weeks, as combined dual treatment with amlodipine at 16 weeks and as combined triple treatment with amlodipine and indapamide at 24 weeks.
Ambulatory blood pressure measurements (metric unit: mmHg) at baseline and 8,16 and 24 weeks and evaluation of the difference of mean ambulatory systolic and diastolic blood pressure measurements between baseline and each time frame in all participants
Measured: 8, 16 and 24 weeks

Secondary outcomes (1)

Difference in change of office BP from baseline, in the eplerenone arm versus the valsartan arm as monotherapy at 8 weeks, as combined dual treatment with amlodipine at 16 weeks and as combined triple treatment with amlodipine and indapamide at 24 weeks.
Office blood pressure measurements (metric unit: mmHg) at baseline and 8,16 and 24 weeks and evaluation of the difference of office systolic and diastolic blood pressure measurements between baseline and each time frame in all participants
Measured: 8, 16 and 24 weeks

Timeline

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

1 Sep 201830 Jun 2025

First posted26 Mar 2018
Study start1 Sep 2018
Primary completion30 Jun 2025
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03476616
Sponsor's protocol ID: HEBRO
Acronym: HEBRO
Status last verified: Jul 2025
First submitted: 19 Mar 2018
Last updated: 31 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tsioufis C, Tsiachris D, Dimitriadis K, Thomopoulos C, Syrseloudis D, Andrikou E, Chatzis D, Taxiarchou E, Selima M, Mazaraki A, Chararis G, Tolis P, Gennadi A, Andrikou I, Stefanadi E, Fragoulis V, Tzamou V, Panagiotakos D, Tousoulis D, Stefanadis C. Leontio Lyceum ALbuminuria (3L Study) epidemiological study: aims, design and preliminary findings. Hellenic J Cardiol. 2009 Nov-Dec;50(6):476-83.
PubMed 19942561
Schlaich MP, Grassi G, Lambert GW, Straznicky N, Esler MD, Dixon J, Lambert EA, Redon J, Narkiewicz K, Jordan J; European Society of Hypertension Working Group on Obesity; Australian and New Zealand Obesity Society. European Society of Hypertension Working Group on Obesity Obesity-induced hypertension and target organ damage: current knowledge and future directions. J Hypertens. 2009 Feb;27(2):207-11. doi: 10.1097/HJH.0b013e32831dafaf. No abstract available.
PubMed 19155773
Dimitriadis K, Tsioufis C, Mazaraki A, Liatakis I, Koutra E, Kordalis A, Kasiakogias A, Flessas D, Tentolouris N, Tousoulis D. Waist circumference compared with other obesity parameters as determinants of coronary artery disease in essential hypertension: a 6-year follow-up study. Hypertens Res. 2016 Jun;39(6):475-9. doi: 10.1038/hr.2016.8. Epub 2016 Feb 11.
PubMed 26865004
Tsioufis CP, Tsiachris DL, Selima MN, Dimitriadis KS, Thomopoulos CG, Tsiliggiris DC, Gennadi AS, Syrseloudis DC, Stefanadi ES, Toutouzas KP, Kallikazaros IE, Stefanadis CI. Impact of waist circumference on cardiac phenotype in hypertensives according to gender. Obesity (Silver Spring). 2009 Jan;17(1):177-82. doi: 10.1038/oby.2008.462. Epub 2008 Oct 23.
PubMed 18948974
Jordan J, Yumuk V, Schlaich M, Nilsson PM, Zahorska-Markiewicz B, Grassi G, Schmieder RE, Engeli S, Finer N. Joint statement of the European Association for the Study of Obesity and the European Society of Hypertension: obesity and difficult to treat arterial hypertension. J Hypertens. 2012 Jun;30(6):1047-55. doi: 10.1097/HJH.0b013e3283537347.
PubMed 22573071
Badimon L, Bugiardini R, Cenko E, Cubedo J, Dorobantu M, Duncker DJ, Estruch R, Milicic D, Tousoulis D, Vasiljevic Z, Vilahur G, de Wit C, Koller A. Position paper of the European Society of Cardiology-working group of coronary pathophysiology and microcirculation: obesity and heart disease. Eur Heart J. 2017 Jul 1;38(25):1951-1958. doi: 10.1093/eurheartj/ehx181. No abstract available.
PubMed 28873951
Doll S, Paccaud F, Bovet P, Burnier M, Wietlisbach V. Body mass index, abdominal adiposity and blood pressure: consistency of their association across developing and developed countries. Int J Obes Relat Metab Disord. 2002 Jan;26(1):48-57. doi: 10.1038/sj.ijo.0801854.
PubMed 11791146
Mancia G, Bombelli M, Corrao G, Facchetti R, Madotto F, Giannattasio C, Trevano FQ, Grassi G, Zanchetti A, Sega R. Metabolic syndrome in the Pressioni Arteriose Monitorate E Loro Associazioni (PAMELA) study: daily life blood pressure, cardiac damage, and prognosis. Hypertension. 2007 Jan;49(1):40-7. doi: 10.1161/01.HYP.0000251933.22091.24. Epub 2006 Nov 27.
PubMed 17130308
Tsioufis C, Tatsis I, Thomopoulos C, Wilcox C, Palm F, Kordalis A, Katsiki N, Papademetriou V, Stefanadis C. Effects of hypertension, diabetes mellitus, obesity and other factors on kidney haemodynamics. Curr Vasc Pharmacol. 2014 May;12(3):537-48. doi: 10.2174/157016111203140518173700.
PubMed 23305375
Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM; ALLHAT Collaborative Research Group. Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-404. doi: 10.1111/j.1524-6175.2002.02045.x.
PubMed 12461301
Hall JE, Brands MW, Dixon WN, Smith MJ Jr. Obesity-induced hypertension. Renal function and systemic hemodynamics. Hypertension. 1993 Sep;22(3):292-9. doi: 10.1161/01.hyp.22.3.292.
PubMed 8349321
Engeli S, Negrel R, Sharma AM. Physiology and pathophysiology of the adipose tissue renin-angiotensin system. Hypertension. 2000 Jun;35(6):1270-7. doi: 10.1161/01.hyp.35.6.1270.
PubMed 10856276
de Paula RB, da Silva AA, Hall JE. Aldosterone antagonism attenuates obesity-induced hypertension and glomerular hyperfiltration. Hypertension. 2004 Jan;43(1):41-7. doi: 10.1161/01.HYP.0000105624.68174.00. Epub 2003 Nov 24.
PubMed 14638627
Garg R, Kneen L, Williams GH, Adler GK. Effect of mineralocorticoid receptor antagonist on insulin resistance and endothelial function in obese subjects. Diabetes Obes Metab. 2014 Mar;16(3):268-72. doi: 10.1111/dom.12224. Epub 2013 Oct 31.
PubMed 24125483
de Souza F, Muxfeldt E, Fiszman R, Salles G. Efficacy of spironolactone therapy in patients with true resistant hypertension. Hypertension. 2010 Jan;55(1):147-52. doi: 10.1161/HYPERTENSIONAHA.109.140988. Epub 2009 Oct 26.
PubMed 19858405

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypertension thErapy With irBesartan Versus EpleRenone for Obese Patients: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03476616
Acronym / sponsor ID: HEBRO / HEBRO
Conditions: Hypertension, Obesity
Keywords: Hypertension, Obesity, Ambulatory Blood Pressure, Eplerenone, Valsartan, Mineralocorticoid Receptor Antagonists, Angiotensin II Receptor Blockers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Hippocration General HospitalUniversity, hospital or other
Study start: 1 Sep 2018 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 26 Mar 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Eplerenone (-based therapy) arm	Active comparator	Drug: Eplerenone (-based therapy) armObese pts with hypertension, starting treatment with eplerenone 25mg twice daily (BD). ABPM wil be scheduled at wks 8, 16 and 24. At wk 8 if mean ABPM < 130/80mm Hg will continue to monotherapy with eplerenone. If not controlled (mean ABPM > 130/80mm Hg) at wk8, amlodipine 5mg OD will be added. At wk 16 if mean ABPM < 130/80mm Hg will continue to monotherapy with eplerenone, or dual therapy with eplerenone and amlodipine. If not controlled (mean ABPM > 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks.
Irbesartan (-based therapy) arm	Active comparator	Drug: Valsartan (-based therapy) armObese pts with hypertension, starting treatment with irbesartan 150mg once daily (OD). ABPM wil be scheduled at wks 8, 16 and 24. At wk 8 if mean ABPM < 130/80mm Hg will continue to monotherapy with irbesartan. If not controlled (mean ABPM > 130/80mm Hg) at wk8, amlodipine 5mg OD will be added. At wk 16 if mean ABPM < 130/80mm Hg will continue to monotherapy with irbesartan, or dual therapy with irbesartan and amlodipine. If not controlled (mean ABPM > 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

30-75 years of age
Written consent
Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg, confirmed by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg
Obesity, confirmed estimated by Body Mass Index (BMI) of 30-40 kg/m2

Key exclusion criteria (29 listed)

Age <30 or >75
Inability to give informed consent
Participation in a clinical study involving an investigational drug or device within 4 weeks of screening
Secondary hypertension
Recent (<6 months) cardiovascular event requiring hospitalization (eg. myocardial infarction or stroke)

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
Eplerenone (-based therapy) armAt randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.	Drug	Eplerenone (-based therapy) arm
Valsartan (-based therapy) armAt randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.	Drug	Irbesartan (-based therapy) arm

Primary outcome

Difference in change of ABPM from baseline, in the eplerenone arm versus the irbesartan arm as monotherapy at 8 weeks, as combined dual treatment with amlodipine at 16 weeks and as combined triple treatment with amlodipine and indapamide at 24 weeks.
Time frame: 8, 16 and 24 weeks
Ambulatory blood pressure measurements (metric unit: mmHg) at baseline and 8,16 and 24 weeks and evaluation of the difference of mean ambulatory systolic and diastolic blood pressure measurements between baseline and each time frame in all participants

1 secondary outcome

Difference in change of office BP from baseline, in the eplerenone arm versus the valsartan arm as monotherapy at 8 weeks, as combined dual treatment with amlodipine at 16 weeks and as combined triple treatment with amlodipine and indapamide at 24 weeks.
Time frame: 8, 16 and 24 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 31 Jul 2025.
Background: PubMed 19942561Tsioufis C, Tsiachris D, Dimitriadis K, Thomopoulos C, Syrseloudis D, Andrikou E, Chatzis D, Taxiarchou E, Selima M, Mazaraki A, Chararis G, Tolis P, Gennadi A, Andrikou I, Stefanadi E, Fragoulis V, Tzamou V, Panagiotakos D, Tousoulis D, Stefanadis C. Leontio Lyceum ALbuminuria (3L Study) epidemiological study: aims, design and preliminary findings. Hellenic J Cardiol. 2009 Nov-Dec;50(6):476-83.
Background: PubMed 19155773Schlaich MP, Grassi G, Lambert GW, Straznicky N, Esler MD, Dixon J, Lambert EA, Redon J, Narkiewicz K, Jordan J; European Society of Hypertension Working Group on Obesity; Australian and New Zealand Obesity Society. European Society of Hypertension Working Group on Obesity Obesity-induced hypertension and target organ damage: current knowledge and future directions. J Hypertens. 2009 Feb;27(2):207-11. doi: 10.1097/HJH.0b013e32831dafaf. No abstract available.
Background: PubMed 26865004Dimitriadis K, Tsioufis C, Mazaraki A, Liatakis I, Koutra E, Kordalis A, Kasiakogias A, Flessas D, Tentolouris N, Tousoulis D. Waist circumference compared with other obesity parameters as determinants of coronary artery disease in essential hypertension: a 6-year follow-up study. Hypertens Res. 2016 Jun;39(6):475-9. doi: 10.1038/hr.2016.8. Epub 2016 Feb 11.
Background: PubMed 18948974Tsioufis CP, Tsiachris DL, Selima MN, Dimitriadis KS, Thomopoulos CG, Tsiliggiris DC, Gennadi AS, Syrseloudis DC, Stefanadi ES, Toutouzas KP, Kallikazaros IE, Stefanadis CI. Impact of waist circumference on cardiac phenotype in hypertensives according to gender. Obesity (Silver Spring). 2009 Jan;17(1):177-82. doi: 10.1038/oby.2008.462. Epub 2008 Oct 23.
Background: PubMed 22573071Jordan J, Yumuk V, Schlaich M, Nilsson PM, Zahorska-Markiewicz B, Grassi G, Schmieder RE, Engeli S, Finer N. Joint statement of the European Association for the Study of Obesity and the European Society of Hypertension: obesity and difficult to treat arterial hypertension. J Hypertens. 2012 Jun;30(6):1047-55. doi: 10.1097/HJH.0b013e3283537347.
Background: PubMed 28873951Badimon L, Bugiardini R, Cenko E, Cubedo J, Dorobantu M, Duncker DJ, Estruch R, Milicic D, Tousoulis D, Vasiljevic Z, Vilahur G, de Wit C, Koller A. Position paper of the European Society of Cardiology-working group of coronary pathophysiology and microcirculation: obesity and heart disease. Eur Heart J. 2017 Jul 1;38(25):1951-1958. doi: 10.1093/eurheartj/ehx181. No abstract available.
Background: PubMed 11791146Doll S, Paccaud F, Bovet P, Burnier M, Wietlisbach V. Body mass index, abdominal adiposity and blood pressure: consistency of their association across developing and developed countries. Int J Obes Relat Metab Disord. 2002 Jan;26(1):48-57. doi: 10.1038/sj.ijo.0801854.
Background: PubMed 17130308Mancia G, Bombelli M, Corrao G, Facchetti R, Madotto F, Giannattasio C, Trevano FQ, Grassi G, Zanchetti A, Sega R. Metabolic syndrome in the Pressioni Arteriose Monitorate E Loro Associazioni (PAMELA) study: daily life blood pressure, cardiac damage, and prognosis. Hypertension. 2007 Jan;49(1):40-7. doi: 10.1161/01.HYP.0000251933.22091.24. Epub 2006 Nov 27.
Background: PubMed 23305375Tsioufis C, Tatsis I, Thomopoulos C, Wilcox C, Palm F, Kordalis A, Katsiki N, Papademetriou V, Stefanadis C. Effects of hypertension, diabetes mellitus, obesity and other factors on kidney haemodynamics. Curr Vasc Pharmacol. 2014 May;12(3):537-48. doi: 10.2174/157016111203140518173700.
Background: PubMed 12461301Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM; ALLHAT Collaborative Research Group. Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-404. doi: 10.1111/j.1524-6175.2002.02045.x.
Background: PubMed 8349321Hall JE, Brands MW, Dixon WN, Smith MJ Jr. Obesity-induced hypertension. Renal function and systemic hemodynamics. Hypertension. 1993 Sep;22(3):292-9. doi: 10.1161/01.hyp.22.3.292.
Background: PubMed 10856276Engeli S, Negrel R, Sharma AM. Physiology and pathophysiology of the adipose tissue renin-angiotensin system. Hypertension. 2000 Jun;35(6):1270-7. doi: 10.1161/01.hyp.35.6.1270.
PROTOCOL OF THE HYPERTENSION THERAPY WITH IRBESARTAN VERSUS EPLERENONE FOR OBESE HYPERTENSIVE PATIENTS (HEBRO)Link provided by the sponsor.
EPLERENONE VS IRBESARTAN AS FIRST LINE THERAPY IN OBESE HYPERTENSIVE PATIENTS: BASELINE CHARACTERISTICSLink provided by the sponsor.
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.

Konstantinos P Tsioufis, Ass. Prof. principal investigator

Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Greece

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 Eplerenone (-based therapy) arm and Valsartan (-based therapy) arm in people with Hypertension and Obesity, run by Hippocration General Hospital at 1 site in Greece.

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 29 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 31 Jul 2025. 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 Greece. 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?

Difference in change of ABPM from baseline, in the eplerenone arm versus the irbesartan arm as monotherapy at 8 weeks, as combined dual treatment with amlodipine at 16 weeks and as combined triple treatment with amlodipine and indapamide at 24 weeks. (time frame: 8, 16 and 24 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 NCT03476616, which also lists 18 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 31 Jul 2025.