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Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients (HEVRO)

Primary Purpose

Hypertension, Obesity

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Eplerenone (-based therapy) arm
Valsartan (-based therapy) arm
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Obesity, Ambulatory Blood Pressure, Eplerenone, Valsartan, Mineralocorticoid Receptor Antagonists, Angiotensin II Receptor Blockers

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 30-75 years of age
  2. Written consent
  3. 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
  4. Obesity, confirmed estimated by Body Mass Index (BMI) of 30-40 kg/m2

Exclusion Criteria

  1. Age <30 or >75
  2. Inability to give informed consent
  3. Participation in a clinical study involving an investigational drug or device within 4 weeks of screening
  4. Secondary hypertension
  5. Recent (<6 months) cardiovascular event requiring hospitalization (eg. myocardial infarction or stroke)
  6. Type 1 diabetes
  7. Chronic kidney disease assessed by Estimated Glomerular Filtration Rate (eGFR) <45 mL/min
  8. Bilateral renal arteries stenosis
  9. Addison's disease
  10. Hemodynamically significant valvular heart disease
  11. Plasma potassium outside of normal range on two successive measurements during screening
  12. Pregnancy, planning to conceive or women of childbearing potential, that is, not using effective contraception
  13. Scheduled surgery or cardiovascular surgery over the next 6 months
  14. Absolute contra-indication to study drugs (eg. asthma) or previous intolerance of trial therapy
  15. History of sustained atrial fibrillation
  16. Requirement for study drug for reason other than to treat hypertension, (eg, β-blockers for angina or aldosterone antagonists for heart failure)
  17. Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy)
  18. Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or
  19. severely limit that patients' life-span or ability to complete the study (eg, alcohol or drug abuse, disabling or terminal illness, mental
  20. disorders)
  21. Contemporary systemic disease with life expectancy shorter than the end of the study

  22. 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eplerenone (-based therapy) arm

Valsartan (-based therapy) arm

Arm Description

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.

Obese pts with hypertension, starting treatment with valsartan 160mg 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 valsartan. 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 valsartan, or dual therapy with valsartan 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.

Outcomes

Primary Outcome Measures

Difference in change of ABPM 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.
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

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2018
Last Updated
August 2, 2018
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03476616
Brief Title
Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients
Acronym
HEVRO
Official Title
HYpertension Therapy With Valsartan Versus EpleRenone for Obese Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hippocration General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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 valsartan-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 valsartan (V) 160mg 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 hypertension (mean ambulatory blood pressure measurement (ABPM) <130/80mmHg), will continue in monotherapy with eplerenone or valsartan 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), (V) or dual therapy (E+C), (V+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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obesity
Keywords
Hypertension, Obesity, Ambulatory Blood Pressure, Eplerenone, Valsartan, Mineralocorticoid Receptor Antagonists, Angiotensin II Receptor Blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone (-based therapy) arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Valsartan (-based therapy) arm
Arm Type
Active Comparator
Arm Description
Obese pts with hypertension, starting treatment with valsartan 160mg 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 valsartan. 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 valsartan, or dual therapy with valsartan 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.
Intervention Type
Drug
Intervention Name(s)
Eplerenone (-based therapy) arm
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Valsartan (-based therapy) arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in change of ABPM 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.
Description
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
Time Frame
8, 16 and 24 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
8, 16 and 24 weeks
Other Pre-specified Outcome Measures:
Title
Difference in frequency of controlled hypertension (mean ABPM < 130/80 mm Hg) between the study arms at 8, 16 and 24 weeks.
Description
Ambulatory blood pressure monitoring (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
Time Frame
8, 16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos P Tsioufis, Ass. Prof.
Phone
6932586087
Ext
+30
Email
ktsioufis@hippocratio.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Panayiotis P Iliakis, MD
Phone
6937489286
Ext
+30
Email
panayiotisiliakis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos P Tsioufis, Ass. Prof.
Organizational Affiliation
Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Athens, Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos P Tsioufis, Ass. Prof.
Phone
6932586087
Ext
+30
Email
ktsioufis@hippocratio.gr
First Name & Middle Initial & Last Name & Degree
Panayiotis P Iliakis, MD
Phone
6937489286
Ext
+30
Email
panayiotisiliakis@gmail.com
First Name & Middle Initial & Last Name & Degree
Konstantinos P Tsioufis, Ass. Prof.
First Name & Middle Initial & Last Name & Degree
Kyriakos S Dimitriadis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Panayiotis P Iliakis, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19942561
Citation
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.
Results Reference
result
PubMed Identifier
19155773
Citation
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.
Results Reference
result
PubMed Identifier
26865004
Citation
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.
Results Reference
result
PubMed Identifier
18948974
Citation
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. Erratum In: Obesity (Silver Spring). 2021 Apr;29(4):767.
Results Reference
result
PubMed Identifier
22573071
Citation
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.
Results Reference
result
PubMed Identifier
28873951
Citation
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.
Results Reference
result
PubMed Identifier
11791146
Citation
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.
Results Reference
result
PubMed Identifier
17130308
Citation
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.
Results Reference
result
PubMed Identifier
23305375
Citation
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.
Results Reference
result
PubMed Identifier
12461301
Citation
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.
Results Reference
result
PubMed Identifier
8349321
Citation
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.
Results Reference
result
PubMed Identifier
10856276
Citation
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.
Results Reference
result
PubMed Identifier
14638627
Citation
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.
Results Reference
result
PubMed Identifier
24125483
Citation
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.
Results Reference
result
PubMed Identifier
19858405
Citation
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.
Results Reference
result
PubMed Identifier
25501057
Citation
Vaclavik J, Sedlak R, Jarkovsky J, Kocianova E, Taborsky M. Effect of spironolactone in resistant arterial hypertension: a randomized, double-blind, placebo-controlled trial (ASPIRANT-EXT). Medicine (Baltimore). 2014 Dec;93(27):e162. doi: 10.1097/MD.0000000000000162.
Results Reference
result
PubMed Identifier
26414968
Citation
Williams B, MacDonald TM, Morant S, Webb DJ, Sever P, McInnes G, Ford I, Cruickshank JK, Caulfield MJ, Salsbury J, Mackenzie I, Padmanabhan S, Brown MJ; British Hypertension Society's PATHWAY Studies Group. Spironolactone versus placebo, bisoprolol, and doxazosin to determine the optimal treatment for drug-resistant hypertension (PATHWAY-2): a randomised, double-blind, crossover trial. Lancet. 2015 Nov 21;386(10008):2059-2068. doi: 10.1016/S0140-6736(15)00257-3. Epub 2015 Sep 20.
Results Reference
result
PubMed Identifier
23817082
Citation
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
Results Reference
result

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Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients

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