ACE InhibitorsNCT04899206
ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
An observational study of ACE Inhibitors and ARB, run by Sebastian Videla at 1 site in Spain.
Trial summary
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACE Inhibitors, ARB, Hypertension
- What is being tested?
- With an Antidepressant Drug and Without an Antidepressant Drug
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2021to 20 Dec 2025
- How long will I take part?
- 38 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with antihypertensive drugs within the Bellvitge University Hospital's influence area (Barcelona's southern metropolitan area).
Who may be able to join
- Patients that had an antihypertensive drug prescribed between January 1st, 2015 and December 31st, 2017, whose ATC codes can be obtained from the 'DATA WAREHOUSE' database
- Age ≥ 18 years old
- Both genders
- Patients with information available on the 'DATA WAREHOUSE' database
- Patients with a clinical visit or prescription done afterwards the date when the information for the study was last collected (this way we ensure that the patient included on the study remained alive after the end of the observation period)
Who cannot join
- Lack of information about the beginning of treatment with an antihypertensive and/or with an antidepressant drug.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907
About this study
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Read the detailed description
Hypertension is a multifactorial disease and an important risk factor for cardiovascular and cerebrovascular diseases. Also, major depression is commonly found on these patients. Together, they represent a substantial burden for patients and their families, with an increased morbimortality and reduced life-quality. It also has a major social impact by increasing healthcare assistance demand and by affecting patients' daily-life productivity, therefore generating direct and indirect health-associated costs.
The Renin-Angiotensin System is one of the known pathways that modulate systemic and central nervous system inflammation. Basic research studies have shown ARBs-related allosteric changes on receptors implicated on the pathophysiology of schizophrenia and depression, and also a pharmacological reversal of depression-like behavior in rats after the administration of losartan. Human research studies have also presented evidence that points towards an antidepressant effect of some antihypertensive drugs.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).
Our secondary objectives are as follows:
- For ARBs:
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ARBs.
- To estimate the clearance of antidepressant drugs prescription in patients concomitantly treated with ARBs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ARBs.
II. For ACEIs:
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ACEIs.
- To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with ACEIs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ACEIs.
III. For other antihypertensive drugs (i.e., non-angiotensin agents: CCBs, β-blockers, and diuretics):
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with other antihypertensive drugs (non-angiotensin agents).
- To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with other antihypertensive drugs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with other antihypertensive drugs.
IV. To perform an exploratory comparative analysis among the different antihypertensive drugs sub-cohorts.
The protocol (Final Version: February 18th, 2021) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation- Committee, code HUB-FC-2020-01, date April 20th, 2021). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.
- Conditions
- ACE Inhibitors, ARB, Hypertension, Depression
- Being tested
- With an Antidepressant Drug, Without an Antidepressant Drug
- Keywords
- ACEI, ARB, ACE, RAS, Angiotension, Depression, Hypertension
- Medical subject headings
- Hypertension, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With an Antidepressant DrugDrug
Current users of an antidepressant drug.
Without an Antidepressant DrugDrug
Non-current users of an antidepressant drug.
| Study group | Role | What they receive |
|---|---|---|
| ARBs only | Hypertensive patients under pharmacological treatment with ARBs Receives: Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug | |
| ACEIs only | Hypertensive patients under pharmacological treatment with ACEIs Receives: Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug | |
| ARBs + ACEIs | Hypertensive patients under pharmacological treatment with ARBs and ACEIs Receives: Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug | |
| Other Antihypertensive Drugs | Hypertensive patients under pharmacological treatment with non-angiotensin agents (diuretics, calcium channel blockers and/or β-blockers alone or combined among them) Receives: Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug | |
| Angiotensin Agents and Other Antihypertensive Drugs | Hypertensive patients under combined pharmacological treatment with Angiotensin Agents (ACEIs and/or ARBs) and Other Antihypertensives (non-angiotensin agents) Receives: Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients treated with antihypertensive drugs
Number of patients under treatment with antihypertensive drugs
Measured: 3 years
Patients treated with an antidepressant drug
Number of patients under treatment with antidepressant drug
Measured: 3 years
Secondary outcomes (7)
Patients diagnosed with Hypertension
Number of patients diagnosed with Hypertension
Measured: 3 years
Patients diagnosed with Depression
Number of patients diagnosed with Depression
Measured: 3 years
Patients treated with ARBs
Number of patients treated with ARBs
Measured: 3 years
Patients treated with ACEIs
Number of patients treated with ACEIs
Measured: 3 years
Patients treated with other antihypertensive drugs
Number of patients treated with other antihypertensive drugs (i.e., non-ARBs and non-ACEIs).
Measured: 3 years
Patients treated with Amitriptyline
Number of patients treated with Amitriptyline, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice.
Measured: 3 years
Patients treated with Duloxetine
Number of patients treated with Duloxetine, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start12 Apr 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ACE InhibitorsStudies 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
- 0 participants (actual)
- Target duration
- 38 Days
Sponsor and investigators
- Lead sponsor
- Sebastian Videla
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut
- Responsible party
- Sponsor-investigator, Sebastian Videla, Hospital Universitari de Bellvitge
- Investigators
- Sebastián Videla, MD, PhD, Principal investigator, Head of the Clinical Research Support Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899206
- Sponsor's protocol ID
- HUB-FC-2020-01
- Status last verified
- Jun 2025
- First submitted
- 18 May 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Annerbrink K, Jonsson EG, Olsson M, Nilsson S, Sedvall GC, Anckarsater H, Eriksson E. Associations between the angiotensin-converting enzyme insertion/deletion polymorphism and monoamine metabolite concentrations in cerebrospinal fluid. Psychiatry Res. 2010 Sep 30;179(2):231-4. doi: 10.1016/j.psychres.2009.04.018. Epub 2010 May 16.
PubMed 20483169Aso E, Lomoio S, Lopez-Gonzalez I, Joda L, Carmona M, Fernandez-Yague N, Moreno J, Juves S, Pujol A, Pamplona R, Portero-Otin M, Martin V, Diaz M, Ferrer I. Amyloid generation and dysfunctional immunoproteasome activation with disease progression in animal model of familial Alzheimer's disease. Brain Pathol. 2012 Sep;22(5):636-53. doi: 10.1111/j.1750-3639.2011.00560.x. Epub 2012 Jan 13.
PubMed 22188425Bathina S, Das UN. Brain-derived neurotrophic factor and its clinical implications. Arch Med Sci. 2015 Dec 10;11(6):1164-78. doi: 10.5114/aoms.2015.56342. Epub 2015 Dec 11.
PubMed 26788077Borrajo A, Rodriguez-Perez AI, Diaz-Ruiz C, Guerra MJ, Labandeira-Garcia JL. Microglial TNF-alpha mediates enhancement of dopaminergic degeneration by brain angiotensin. Glia. 2014 Jan;62(1):145-57. doi: 10.1002/glia.22595.
PubMed 24272709Brownstein DJ, Salagre E, Kohler C, Stubbs B, Vian J, Pereira C, Chavarria V, Karmakar C, Turner A, Quevedo J, Carvalho AF, Berk M, Fernandes BS. Blockade of the angiotensin system improves mental health domain of quality of life: A meta-analysis of randomized clinical trials. Aust N Z J Psychiatry. 2018 Jan;52(1):24-38. doi: 10.1177/0004867417721654. Epub 2017 Jul 28.
PubMed 28754072Can A, Dao DT, Arad M, Terrillion CE, Piantadosi SC, Gould TD. The mouse forced swim test. J Vis Exp. 2012 Jan 29;(59):e3638. doi: 10.3791/3638.
PubMed 22314943Can A, Dao DT, Terrillion CE, Piantadosi SC, Bhat S, Gould TD. The tail suspension test. J Vis Exp. 2012 Jan 28;(59):e3769. doi: 10.3791/3769.
PubMed 22315011Cao YY, Xiang X, Song J, Tian YH, Wang MY, Wang XW, Li M, Huang Z, Wu Y, Wu T, Wu YQ, Hu YH. Distinct effects of antihypertensives on depression in the real-world setting: A retrospective cohort study. J Affect Disord. 2019 Dec 1;259:386-391. doi: 10.1016/j.jad.2019.08.075. Epub 2019 Aug 24.
PubMed 31470183Clark JD, Gebhart GF, Gonder JC, Keeling ME, Kohn DF. Special Report: The 1996 Guide for the Care and Use of Laboratory Animals. ILAR J. 1997;38(1):41-48. doi: 10.1093/ilar.38.1.41. No abstract available.
PubMed 11528046Deacon RM. Digging and marble burying in mice: simple methods for in vivo identification of biological impacts. Nat Protoc. 2006;1(1):122-4. doi: 10.1038/nprot.2006.20.
PubMed 17406223Farmer ME, Kittner SJ, Abbott RD, Wolz MM, Wolf PA, White LR. Longitudinally measured blood pressure, antihypertensive medication use, and cognitive performance: the Framingham Study. J Clin Epidemiol. 1990;43(5):475-80. doi: 10.1016/0895-4356(90)90136-d.
PubMed 2324788Goodman and Gilman's: The Pharmacological Basis of Therapeutics, 13th edition, New York: McGraw-Hill Medical, 2018.
Grover MP, Ballouz S, Mohanasundaram KA, George RA, Sherman CD, Crowley TM, Wouters MA. Identification of novel therapeutics for complex diseases from genome-wide association data. BMC Med Genomics. 2014;7 Suppl 1(Suppl 1):S8. doi: 10.1186/1755-8794-7-S1-S8. Epub 2014 May 8.
PubMed 25077696Kessing LV, Rytgaard HC, Ekstrom CT, Torp-Pedersen C, Berk M, Gerds TA. Antihypertensive Drugs and Risk of Depression: A Nationwide Population-Based Study. Hypertension. 2020 Oct;76(4):1263-1279. doi: 10.1161/HYPERTENSIONAHA.120.15605. Epub 2020 Aug 24.
PubMed 32829669Kessing LV, Rytgaard HC, Gerds TA, Berk M, Ekstrom CT, Andersen PK. New drug candidates for depression - a nationwide population-based study. Acta Psychiatr Scand. 2019 Jan;139(1):68-77. doi: 10.1111/acps.12957. Epub 2018 Sep 4.
PubMed 30182363
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
- ClinicalTrials.gov ID
- NCT04899206
- Acronym / sponsor ID
- HUB-FC-2020-01
- Conditions
- ACE Inhibitors, ARB, Hypertension, Depression
- Keywords
- ACEI, ARB, ACE, RAS, Angiotension, Depression, Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sebastian VidelaUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català de la Salut
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 24 May 2021 (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.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Detailed description
Hypertension is a multifactorial disease and an important risk factor for cardiovascular and cerebrovascular diseases. Also, major depression is commonly found on these patients. Together, they represent a substantial burden for patients and their families, with an increased morbimortality and reduced life-quality. It also has a major social impact by increasing healthcare assistance demand and by affecting patients' daily-life productivity, therefore generating direct and indirect health-associated costs.
The Renin-Angiotensin System is one of the known pathways that modulate systemic and central nervous system inflammation. Basic research studies have shown ARBs-related allosteric changes on receptors implicated on the pathophysiology of schizophrenia and depression, and also a pharmacological reversal of depression-like behavior in rats after the administration of losartan. Human research studies have also presented evidence that points towards an antidepressant effect of some antihypertensive drugs.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).
Our secondary objectives are as follows:
- For ARBs:
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ARBs.
- To estimate the clearance of antidepressant drugs prescription in patients concomitantly treated with ARBs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ARBs.
II. For ACEIs:
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ACEIs.
- To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with ACEIs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ACEIs.
III. For other antihypertensive drugs (i.e., non-angiotensin agents: CCBs, β-blockers, and diuretics):
- To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with other antihypertensive drugs (non-angiotensin agents).
- To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with other antihypertensive drugs and antidepressant drugs.
- To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with other antihypertensive drugs.
IV. To perform an exploratory comparative analysis among the different antihypertensive drugs sub-cohorts.
The protocol (Final Version: February 18th, 2021) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation- Committee, code HUB-FC-2020-01, date April 20th, 2021). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 38 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ARBs only | – | Drug: With an Antidepressant Drug, Drug: Without an Antidepressant DrugHypertensive patients under pharmacological treatment with ARBs |
| ACEIs only | – | Drug: With an Antidepressant Drug, Drug: Without an Antidepressant DrugHypertensive patients under pharmacological treatment with ACEIs |
| ARBs + ACEIs | – | Drug: With an Antidepressant Drug, Drug: Without an Antidepressant DrugHypertensive patients under pharmacological treatment with ARBs and ACEIs |
| Other Antihypertensive Drugs | – | Drug: With an Antidepressant Drug, Drug: Without an Antidepressant DrugHypertensive patients under pharmacological treatment with non-angiotensin agents (diuretics, calcium channel blockers and/or β-blockers alone or combined among them) |
| Angiotensin Agents and Other Antihypertensive Drugs | – | Drug: With an Antidepressant Drug, Drug: Without an Antidepressant DrugHypertensive patients under combined pharmacological treatment with Angiotensin Agents (ACEIs and/or ARBs) and Other Antihypertensives (non-angiotensin agents) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with antihypertensive drugs within the Bellvitge University Hospital's influence area (Barcelona's southern metropolitan area).
Key inclusion criteria (5 listed)
- Patients that had an antihypertensive drug prescribed between January 1st, 2015 and December 31st, 2017, whose ATC codes can be obtained from the 'DATA WAREHOUSE' database
- Age ≥ 18 years old
- Both genders
- Patients with information available on the 'DATA WAREHOUSE' database
- Patients with a clinical visit or prescription done afterwards the date when the information for the study was last collected (this way we ensure that the patient included on the study remained alive after the end of the observation period)
Key exclusion criteria (1 listed)
- Lack of information about the beginning of treatment with an antihypertensive and/or with an antidepressant drug.
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 |
|---|---|---|
| With an Antidepressant DrugCurrent users of an antidepressant drug. | Drug | ACEIs only, ARBs + ACEIs, ARBs only, Angiotensin Agents and Other Antihypertensive Drugs, Other Antihypertensive Drugs |
| Without an Antidepressant DrugNon-current users of an antidepressant drug. | Drug | ACEIs only, ARBs + ACEIs, ARBs only, Angiotensin Agents and Other Antihypertensive Drugs, Other Antihypertensive Drugs |
Primary outcome
Patients treated with antihypertensive drugs
Time frame: 3 years
Number of patients under treatment with antihypertensive drugs
Patients treated with an antidepressant drug
Time frame: 3 years
Number of patients under treatment with antidepressant drug
7 secondary outcomes
Patients diagnosed with Hypertension
Time frame: 3 years
Patients diagnosed with Depression
Time frame: 3 years
Patients treated with ARBs
Time frame: 3 years
Patients treated with ACEIs
Time frame: 3 years
Patients treated with other antihypertensive drugs
Time frame: 3 years
Patients treated with Amitriptyline
Time frame: 3 years
Patients treated with Duloxetine
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 20483169Annerbrink K, Jonsson EG, Olsson M, Nilsson S, Sedvall GC, Anckarsater H, Eriksson E. Associations between the angiotensin-converting enzyme insertion/deletion polymorphism and monoamine metabolite concentrations in cerebrospinal fluid. Psychiatry Res. 2010 Sep 30;179(2):231-4. doi: 10.1016/j.psychres.2009.04.018. Epub 2010 May 16.
- Background: PubMed 22188425Aso E, Lomoio S, Lopez-Gonzalez I, Joda L, Carmona M, Fernandez-Yague N, Moreno J, Juves S, Pujol A, Pamplona R, Portero-Otin M, Martin V, Diaz M, Ferrer I. Amyloid generation and dysfunctional immunoproteasome activation with disease progression in animal model of familial Alzheimer's disease. Brain Pathol. 2012 Sep;22(5):636-53. doi: 10.1111/j.1750-3639.2011.00560.x. Epub 2012 Jan 13.
- Background: PubMed 26788077Bathina S, Das UN. Brain-derived neurotrophic factor and its clinical implications. Arch Med Sci. 2015 Dec 10;11(6):1164-78. doi: 10.5114/aoms.2015.56342. Epub 2015 Dec 11.
- Background: PubMed 24272709Borrajo A, Rodriguez-Perez AI, Diaz-Ruiz C, Guerra MJ, Labandeira-Garcia JL. Microglial TNF-alpha mediates enhancement of dopaminergic degeneration by brain angiotensin. Glia. 2014 Jan;62(1):145-57. doi: 10.1002/glia.22595.
- Background: PubMed 28754072Brownstein DJ, Salagre E, Kohler C, Stubbs B, Vian J, Pereira C, Chavarria V, Karmakar C, Turner A, Quevedo J, Carvalho AF, Berk M, Fernandes BS. Blockade of the angiotensin system improves mental health domain of quality of life: A meta-analysis of randomized clinical trials. Aust N Z J Psychiatry. 2018 Jan;52(1):24-38. doi: 10.1177/0004867417721654. Epub 2017 Jul 28.
- Background: PubMed 22314943Can A, Dao DT, Arad M, Terrillion CE, Piantadosi SC, Gould TD. The mouse forced swim test. J Vis Exp. 2012 Jan 29;(59):e3638. doi: 10.3791/3638.
- Background: PubMed 22315011Can A, Dao DT, Terrillion CE, Piantadosi SC, Bhat S, Gould TD. The tail suspension test. J Vis Exp. 2012 Jan 28;(59):e3769. doi: 10.3791/3769.
- Background: PubMed 31470183Cao YY, Xiang X, Song J, Tian YH, Wang MY, Wang XW, Li M, Huang Z, Wu Y, Wu T, Wu YQ, Hu YH. Distinct effects of antihypertensives on depression in the real-world setting: A retrospective cohort study. J Affect Disord. 2019 Dec 1;259:386-391. doi: 10.1016/j.jad.2019.08.075. Epub 2019 Aug 24.
- Background: PubMed 11528046Clark JD, Gebhart GF, Gonder JC, Keeling ME, Kohn DF. Special Report: The 1996 Guide for the Care and Use of Laboratory Animals. ILAR J. 1997;38(1):41-48. doi: 10.1093/ilar.38.1.41. No abstract available.
- Background: PubMed 17406223Deacon RM. Digging and marble burying in mice: simple methods for in vivo identification of biological impacts. Nat Protoc. 2006;1(1):122-4. doi: 10.1038/nprot.2006.20.
- Background: PubMed 2324788Farmer ME, Kittner SJ, Abbott RD, Wolz MM, Wolf PA, White LR. Longitudinally measured blood pressure, antihypertensive medication use, and cognitive performance: the Framingham Study. J Clin Epidemiol. 1990;43(5):475-80. doi: 10.1016/0895-4356(90)90136-d.
- BackgroundGoodman and Gilman's: The Pharmacological Basis of Therapeutics, 13th edition, New York: McGraw-Hill Medical, 2018.
- Individual participant dataSharing planned: Undecided
Related trials for ACE Inhibitors
Active, not recruitingPhase 3
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
Chronic Kidney Disease, Proteinuria
RecruitingPhase 4
STunning in Acute Myocardial Infarction - BAS
Myocardial Infarct
RecruitingPhase 3
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Chronic Kidney Disease, Proteinuria
RecruitingPhase 2
Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
Chest Wall Tumor, Breast Cancer
RecruitingObservational study
Angioedema Biomarker Research Study
Angioedema, Angioedemas, Hereditary
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.
Sebastián Videla, MD, PhD principal investigator
Head of the Clinical Research Support Unit
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 ACE Inhibitors and ARB, run by Sebastian Videla at 1 site in Spain.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Jun 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patients treated with antihypertensive drugs (time frame: 3 years). The study lists 2 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 NCT04899206, which also lists 27 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 5 Jun 2025.