Resistant HypertensionNCT07877844
Prevalence, Clinical Characteristics and Treatment of Bulgarian Patients With Resistant Hypertension
An observational study of Resistant Hypertension and Controlled Hypertension, run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
Study objectives: Our study aimed to assess the prevalence, characteristics, and treatment of patients with resistant hypertension (HTN) in Bulgarian hypertensive population. Methods: We screened 4340 consecutive cardiovascular patients hospitalized in our clinic and identified 3762 with HTN. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Resistant Hypertension, Controlled Hypertension
- How many people
- 256 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Jul 2018to 30 Apr 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As a first step, we consecutively screened 4340 patients for HTN. Screening included patients hospitalized at our clinic with various cardiovascular pathologies/diagnoses from 1 July 2018, to 27 March 2024. We identified HTN in 3762 (86.7%) of all patients. In the next step, the hypertensive population was screened for resistant HTN using criteria recommended by the 2018 ESC/ESH Guidelines and 2023 ESH Guidelines for the management of arterial hypertension
Who may be able to join
None listed.
Who cannot join
- patients with HTN at target BP values achieved using ≤3 antihypertensive drugs; (2) patients with uncontrolled HTN using
- ≥3 drugs, but not at optimal doses or not including ACEi/ARB + CCB + thiazide/thiazide-like diuretic or a treatment period of <1 month; (3) an established diagnosis of "secondary HTN"; (4) suspected/confirmed pseudo-resistant HTN; and (5) patient clinical condition and/or comorbid factors/diseases making the planned instrumental investigations unfeasible.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Deparment of Internal Diseases "Prof. St. Kirkovich", UMHAT "Alexandrovska", Medical University of Sofia
Sofia, Sofia, 1431
About this study
Official title: Prevalence, Clinical Characteristics and Treatment of Bulgarian Patients With Resistant Arterial Hypertension: a Single-center Study.
Study objectives: Our study aimed to assess the prevalence, characteristics, and treatment of patients with resistant hypertension (HTN) in Bulgarian hypertensive population.
Methods: We screened 4340 consecutive cardiovascular patients hospitalized in our clinic and identified 3762 with HTN. Of them, 128 fulfilled the current (2018) European Society of Cardiology and (2023) European Society of Hypertension criteria for resistant HTN and were included in our study. We matched these patients to 128 hospitalized patients with controlled HTN.
Read the detailed description
We conducted an observational, retrospective, non-interventional study. As a first step, we consecutively screened 4340 patients for HTN. Screening included patients hospitalized at our clinic with various cardiovascular pathologies/diagnoses from 1 July 2018, to 27 March 2024. We identified HTN in 3762 (86.7%) of all patients. In the next step, the hypertensive population was screened for resistant HTN using criteria recommended by the 2018 European Society of Cardiology (ESC)/European Society of Hypertension (ESH) Guidelines and 2023 ESH Guidelines for the management of arterial hypertension. Inclusion criteria for our study were as follows: (1) age ≥ 18 years; (2) an established diagnosis of "Arterial hypertension" according to the 2018 ESC/ESH Guidelines and/or 2023 ESH Guidelines for the diagnosis and treatment of this disease; (3) maintenance of office SBP ≥ 140 mmHg and/or office DBP ≥ 90 mmHg after ≥1 month of treatment with optimal or best-tolerated doses of three or more drugs, including a thiazide/thiazide-like diuretic, an RAAS blocker (either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB)), and a calcium channel blocker (CCB); (4) uncontrolled HTN confirmed by 24-h Holter-BP monitoring; (5) good adherence to the prescribed treatment (≥80% of the treatment period); and (6) patient agreement and signed informed consent at hospital admission to participate in all planned physical, instrumental, and laboratory investigations.
Exclusion criteria for the study were as follows: (1) patients with HTN at target BP values achieved using ≤3 antihypertensive drugs; (2) patients with uncontrolled HTN using ≥3 drugs, but not at optimal doses or not including ACEi/ARB + CCB + thiazide/thiazide-like diuretic or a treatment period of <1 month; (3) an established diagnosis of "secondary HTN"; (4) suspected/confirmed pseudo-resistant HTN; and (5) patient clinical condition and/or comorbid factors/diseases making the planned instrumental investigations unfeasible. After applying these criteria, we identified 128 patients with resistant HTN, representing 2.9% of all cardiovascular patients (n = 4340) screened and 3.4% of the hypertensive population (n = 3762) in our study. Of the patients with resistant HTN, 63 (49.2%) were male, and 65 (50.8%) were female (p = 0.860). The median age was 58.0 years, with an interquartile range (IQR) of 46.0-69.0 years. In the third step, we used propensity score matching to match 128 hospitalized hypertensives with controlled HTN.
- Conditions
- Resistant Hypertension, Controlled Hypertension
- Keywords
- resistant, hypertension, prevalence, characteristics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resistant HTN | Patients with 2018 ESC/2023 ESH guidelines criteria for resistant hypertension | |
| Controlled HTN | Patients with 2018 ESC/2023 ESH guidelines criteria for controlled hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment resistance
Resistance to 3 or more antihypertensive drugs
Measured: 2018-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jul 2018
- Primary completion27 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Naydenov Naydenov, Medical University of Sofia
- Investigators
- Stefan N Naydenov, PhD, MD, Principal investigator, Department of Internal Diseases "Prof. St. Kirkovich", Medical University of Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877844
- Sponsor's protocol ID
- KPVB0001RH
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with other researchers. Study findings will be disseminated through publications and presentations using aggregate data.
Publications
Carey RM, Calhoun DA, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, Lackland DT, Laffer CL, Newton-Cheh C, Smith SM, Taler SJ, Textor SC, Turan TN, White WB; American Heart Association Professional/Public Education and Publications Committee of the Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Genomic and Precision Medicine; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018 Nov;72(5):e53-e90. doi: 10.1161/HYP.0000000000000084.
PubMed 30354828Sinnott SJ, Smeeth L, Williamson E, Douglas IJ. Trends for prevalence and incidence of resistant hypertension: population based cohort study in the UK 1995-2015. BMJ. 2017 Sep 22;358:j3984. doi: 10.1136/bmj.j3984.
PubMed 28939590Noubiap JJ, Nansseu JR, Nyaga UF, Sime PS, Francis I, Bigna JJ. Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients. Heart. 2019 Jan;105(2):98-105. doi: 10.1136/heartjnl-2018-313599. Epub 2018 Aug 7.
PubMed 30087099Hiremath S, Sapir-Pichhadze R, Nakhla M, Gabor JY, Khan NA, Kuyper LM, Ruzicka M, Tobe SW, Tran K, Rabi DM, Daskalopoulou SS. Hypertension Canada's 2020 Evidence Review and Guidelines for the Management of Resistant Hypertension. Can J Cardiol. 2020 May;36(5):625-634. doi: 10.1016/j.cjca.2020.02.083.
PubMed 32389336Matanes F, Khan MB, Siddiqui M, Dudenbostel T, Calhoun D, Oparil S. An Update on Refractory Hypertension. Curr Hypertens Rep. 2022 Jul;24(7):225-234. doi: 10.1007/s11906-022-01185-6. Epub 2022 Apr 6.
PubMed 35384577NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
PubMed 34450083Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
PubMed 29133354Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
PubMed 32370572Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
PubMed 37345492Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
PubMed 30234752
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Clinical Characteristics and Treatment of Bulgarian Patients With Resistant Arterial Hypertension: a Single-center Study.
- ClinicalTrials.gov ID
- NCT07877844
- Acronym / sponsor ID
- KPVB0001RH
- Conditions
- Resistant Hypertension, Controlled Hypertension
- Keywords
- resistant, hypertension, prevalence, characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 16 Oct 2026 (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.
Study objectives: Our study aimed to assess the prevalence, characteristics, and treatment of patients with resistant hypertension (HTN) in Bulgarian hypertensive population.
Methods: We screened 4340 consecutive cardiovascular patients hospitalized in our clinic and identified 3762 with HTN. Of them, 128 fulfilled the current (2018) European Society of Cardiology and (2023) European Society of Hypertension criteria for resistant HTN and were included in our study. We matched these patients to 128 hospitalized patients with controlled HTN.
Detailed description
We conducted an observational, retrospective, non-interventional study. As a first step, we consecutively screened 4340 patients for HTN. Screening included patients hospitalized at our clinic with various cardiovascular pathologies/diagnoses from 1 July 2018, to 27 March 2024. We identified HTN in 3762 (86.7%) of all patients. In the next step, the hypertensive population was screened for resistant HTN using criteria recommended by the 2018 European Society of Cardiology (ESC)/European Society of Hypertension (ESH) Guidelines and 2023 ESH Guidelines for the management of arterial hypertension. Inclusion criteria for our study were as follows: (1) age ≥ 18 years; (2) an established diagnosis of "Arterial hypertension" according to the 2018 ESC/ESH Guidelines and/or 2023 ESH Guidelines for the diagnosis and treatment of this disease; (3) maintenance of office SBP ≥ 140 mmHg and/or office DBP ≥ 90 mmHg after ≥1 month of treatment with optimal or best-tolerated doses of three or more drugs, including a thiazide/thiazide-like diuretic, an RAAS blocker (either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB)), and a calcium channel blocker (CCB); (4) uncontrolled HTN confirmed by 24-h Holter-BP monitoring; (5) good adherence to the prescribed treatment (≥80% of the treatment period); and (6) patient agreement and signed informed consent at hospital admission to participate in all planned physical, instrumental, and laboratory investigations.
Exclusion criteria for the study were as follows: (1) patients with HTN at target BP values achieved using ≤3 antihypertensive drugs; (2) patients with uncontrolled HTN using ≥3 drugs, but not at optimal doses or not including ACEi/ARB + CCB + thiazide/thiazide-like diuretic or a treatment period of <1 month; (3) an established diagnosis of "secondary HTN"; (4) suspected/confirmed pseudo-resistant HTN; and (5) patient clinical condition and/or comorbid factors/diseases making the planned instrumental investigations unfeasible. After applying these criteria, we identified 128 patients with resistant HTN, representing 2.9% of all cardiovascular patients (n = 4340) screened and 3.4% of the hypertensive population (n = 3762) in our study. Of the patients with resistant HTN, 63 (49.2%) were male, and 65 (50.8%) were female (p = 0.860). The median age was 58.0 years, with an interquartile range (IQR) of 46.0-69.0 years. In the third step, we used propensity score matching to match 128 hospitalized hypertensives with controlled HTN.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant HTN | – | –Patients with 2018 ESC/2023 ESH guidelines criteria for resistant hypertension |
| Controlled HTN | – | –Patients with 2018 ESC/2023 ESH guidelines criteria for controlled hypertension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As a first step, we consecutively screened 4340 patients for HTN. Screening included patients hospitalized at our clinic with various cardiovascular pathologies/diagnoses from 1 July 2018, to 27 March 2024. We identified HTN in 3762 (86.7%) of all patients. In the next step, the hypertensive population was screened for resistant HTN using criteria recommended by the 2018 ESC/ESH Guidelines and 2023 ESH Guidelines for the management of arterial hypertension
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- patients with HTN at target BP values achieved using ≤3 antihypertensive drugs; (2) patients with uncontrolled HTN using
- ≥3 drugs, but not at optimal doses or not including ACEi/ARB + CCB + thiazide/thiazide-like diuretic or a treatment period of <1 month; (3) an established diagnosis of "secondary HTN"; (4) suspected/confirmed pseudo-resistant HTN; and (5) patient clinical condition and/or comorbid factors/diseases making the planned instrumental investigations unfeasible.
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
Treatment resistance
Time frame: 2018-2024
Resistance to 3 or more antihypertensive drugs
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 16 Oct 2026.
- Background: PubMed 30354828Carey RM, Calhoun DA, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, Lackland DT, Laffer CL, Newton-Cheh C, Smith SM, Taler SJ, Textor SC, Turan TN, White WB; American Heart Association Professional/Public Education and Publications Committee of the Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Genomic and Precision Medicine; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018 Nov;72(5):e53-e90. doi: 10.1161/HYP.0000000000000084.
- Background: PubMed 28939590Sinnott SJ, Smeeth L, Williamson E, Douglas IJ. Trends for prevalence and incidence of resistant hypertension: population based cohort study in the UK 1995-2015. BMJ. 2017 Sep 22;358:j3984. doi: 10.1136/bmj.j3984.
- Background: PubMed 30087099Noubiap JJ, Nansseu JR, Nyaga UF, Sime PS, Francis I, Bigna JJ. Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients. Heart. 2019 Jan;105(2):98-105. doi: 10.1136/heartjnl-2018-313599. Epub 2018 Aug 7.
- Background: PubMed 32389336Hiremath S, Sapir-Pichhadze R, Nakhla M, Gabor JY, Khan NA, Kuyper LM, Ruzicka M, Tobe SW, Tran K, Rabi DM, Daskalopoulou SS. Hypertension Canada's 2020 Evidence Review and Guidelines for the Management of Resistant Hypertension. Can J Cardiol. 2020 May;36(5):625-634. doi: 10.1016/j.cjca.2020.02.083.
- Background: PubMed 35384577Matanes F, Khan MB, Siddiqui M, Dudenbostel T, Calhoun D, Oparil S. An Update on Refractory Hypertension. Curr Hypertens Rep. 2022 Jul;24(7):225-234. doi: 10.1007/s11906-022-01185-6. Epub 2022 Apr 6.
- Background: PubMed 34450083NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
- Background: PubMed 29133354Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
- Background: PubMed 32370572Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
- Background: PubMed 37345492Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
- Background: PubMed 30234752Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with other researchers. Study findings will be disseminated through publications and presentations using aggregate data.
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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.
Stefan N Naydenov, PhD, MD principal investigator
Department of Internal Diseases "Prof. St. Kirkovich", Medical University of Sofia
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 Controlled Hypertension, run by Medical University of Sofia at 1 site in Bulgaria.
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 0 inclusion and 2 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 16 Oct 2026. 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 Bulgaria. 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?
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?
Treatment resistance (time frame: 2018-2024). 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 NCT07877844, which also lists 10 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 16 Oct 2026.