HypertensionNCT06450327
Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus") Syndrome?
An observational study of Hypertension and Resistant Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Resistant arterial hypertension (RAH) is a complex and multifactorial syndrome, with hyperactivity of the sympathetic nervous system (SNS) and reduction of vagal activity being considered some of the main causes of refractoriness to treatment. Seen from the outside, it resembles a complicated (see lat. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Resistant Hypertension
- What is being tested?
- This is a cross-sectional observational study
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Aug 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the Resistant Hypertension Outpatient Clinic of the HC of UNICAMP and FAMERP - Faculty of Medicine of São José do Rio Preto. During the first six months of follow-up, ambulatory BP monitoring (ABPM) and optimization of pharmacological therapy will be carried out, including strict control of treatment adherence (pill count) and dietary guidelines. Furthermore, possible causes of secondary hypertension will be investigated and excluded.
Who may be able to join
- men and women over 35 years of age diagnosed with resistant arterial hypertension (RH), in accordance with the latest international and national guidelines;
- be able to understand, verbalize and answer questions;
- agree to participate in the study and sign the Informed Consent Form;
- after clearly understanding it;
- be under regular follow-up at the UNICAMP Cardiovascular Pharmacology outpatient clinic for at least six months;
- have proven adherence to non-pharmacological and pharmacological treatment;
- women in the reproductive phase must be using a proven effective contraceptive method.
Who cannot join
- clinical history or clinical symptoms of heart failure;
- patients with dilated cardiomyopathies, valvular heart disease, pericardial disorders;
- patients with cerebrovascular disease or peripheral arterial disease, nephropathies, liver diseases, smoking, autoimmune diseases and use of illicit substances;
- any abnormal condition that may interfere with the results of the study or the health of the volunteer, as judged by the researcher;
- women who are pregnant or intend to become pregnant;
- current participation in another investigative study;
- major depression or other relevant psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Tatiane de Azevedo Rubio
Votuporanga, São Paulo, 15505185
TATIANE DE AZEVEDO RUBIO, +55(17)991422510, thatyazevedo@gmail.com
About this study
Official title: Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus")
Resistant arterial hypertension (RAH) is a complex and multifactorial syndrome, with hyperactivity of the sympathetic nervous system (SNS) and reduction of vagal activity being considered some of the main causes of refractoriness to treatment. Seen from the outside, it resembles a complicated (see lat. "Cum plicate") or complex disease (see lat. "Cum plexus"), Chaotic with the participation of several open systems. For example, in recent years some relationships have been demonstrated between the autonomic nervous systems, synaptic mediators, hormones, inflammatory and immune responses. However, these findings have not been investigated together and systematically. In the present project, we intend to establish and compare, in an integrated way, the clinical alterations present in RAH (resistant and refractory), hemodynamic variables, autonomous activity (sympathetic and baroreflex) and interactions with the neuroimmune-endocrine systems. To this end, we will test the hypothesis that resistant patients have greater damage to the autonomic nervous system (ANS) associated with exacerbated systemic and hormonal inflammatory profile, including SNA mediators (noradrenaline and acetylcholinesterase). This is also intended to determine the behavior (deterministic or chaotic) of the systems evaluated (mentioned above) in volunteers with RAH. Sample and methods: The sample space (calculated) will consist of 72 individuals, being: - 18 refractory hypertensive (HRT); II- 18 resistant hypertensive patients (HRfT); III- 18 controlled hypertensive (1-2 drugs) (CAH); and IV- 18 healthy normotensive individuals. This is a prospective, double-blind study (patient and professional-technician), paired (1 X 4), in which the 72 volunteers will be evaluated by the methods set out below. We will also have the chance to observe whether resistant and refractory hypertension share the same pathophysiological bases and clinical manifestations ("deterministic-isolated or cardiovascular chaos") by analyzing the patterns of cardiovascular variability (MAPA and Holter) (SpaceLabs, USA; DynaMap, Brazil), inflammatory and hormonal mediators (ELISA) in the resistant hypertension - RHT and refratary hypertension - HfRT groups. Central pressure (CP) and arterial stiffness (pulse wave velocity, VOP) (Sphymocor, ATCor, USA) will also be assessed. Healthy normotensive (NT) and controlled hypertension (CAH) will be evaluated in an identical way to control the other groups. Perspectives: The findings will improve the clinical knowledge based on pathophysiology about Resistant Hypertension and, mainly, the bases of pharmacological treatment and with implantable devices (stimulation of baroreceptors and sympathetic denervation) used in this condition.
Read the detailed description
Cardiovascular Autonomic Modulation Procedures for spectral analysis of pulse interval (heart rate variability) and systolic blood pressure variability have been described in the literature41-44. Each heartbeat will be identified using a specialized algorithm implemented in Matlab MT software (MATLAB 6.0, Mathworks, USA ) and which automatically detects PAS and PAD waves. The pulse interval or R-R interval will be calculated as the difference between the start and end points of the cycle (t1-t0). The power spectral density of the PAS and R-R interval will be calculated using the Fast Fourier Transform and the Welch method over 16,384 points with a Hanning window and 50% overlap. The spectral bands evaluated for humans were defined according to literature references: very low frequency (MBF: 0.007-0.04Hz), low frequency (BF: 0.04-0.15Hz), high frequency (AF: 0. 15-0.4 Hz) and full power [130]. Baroreflex sensitivity will be inferred from the alpha index (HR BF ratio in ms2 / SBP BF ratio in mmHg).
ABPM - It will be performed with the CardioMAPA Monitor - Cardios - Brazil, with standardized measurements every 15 minutes during the waking period, and every 20 minutes during the sleeping period. The data will be considered valid when monitoring takes place for a minimum period of 21 hours with a minimum number of forty measurements during wakefulness and ten measurements during sleep.
Determination of Central Blood Pressure and Amplification Index (AIx) - The SphygmoCor CPV system (AtCor Medical, USA) is a sophisticated non-invasive diagnostic tool for clinical assessment of central blood pressure. This system derives central aortic pulse wave pressure (systolic, diastolic, and pulse) using pulse wave pressure recorded by the radial artery. Pulse wave analysis predicts parameters including PAC and indications of vascular stiffness. Measurements are made using a pressure transducer (tonometer) positioned in the required artery and then the pulse wave is recorded. Furthermore, this equipment provides information on arterial stiffness by analyzing the Augmentation Index [Amplification Index (AIx)], defined by the ratio between the pressure determined by the reflected wave and the ejection wave capable of providing information on arterial stiffness.
Assessment of Clinical Parameters - BP measurements will be taken according to the recommendations recommended by the VIII Brazilian Guidelines on Arterial Hypertension using a digital sphygmomanometer (Omron HEM-711DLX). Pulse pressure (PP) will be calculated from the difference between SBP and DBP values. All individuals will undergo ambulatory BP monitoring (ABPM) for a period of 24 hours using the Spacelabs 90217 equipment (Spacelabs Inc, Redmon, WA, USA). Patients will be instructed to maintain and record normal daily activities. The averages of SBP, DBP and PP will be evaluated.
Assessment of Biochemical and Inflammatory Parameters - Fasting blood samples will be collected and the following tests will be carried out: glucose, glycated hemoglobin A1C, total cholesterol and fractions, urea, creatinine, renin, aldosterone, cortisol, creatinine clearance and microalbuminuria. The biomarkers norepinephrine, dopamine, adrenaline, adrenocorticotropic hormones (ACTH) and cortisol, acetylcholinesterase, ultrasensitive C-reactive protein, interleukins 2, 8, 10 and 12 (IL-2, IL-8, IL-10 and IL-12) will be determined by ELISA according to the manufacturer's instructions.
- Conditions
- Hypertension, Resistant Hypertension
- Being tested
- This is a cross-sectional observational study
- Keywords
- autonomic nervous system, resistant hypertension, arterial hypertension, refractory hypertension, baroreceptors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a cross-sectional observational studyOther
There will be no intervention in the study.
| Study group | Role | What they receive |
|---|---|---|
| Normotensives - apparently healthy | Group of non-hypertensive participants Receives: Other: This is a cross-sectional observational study | |
| Controlled hypertension | Participants diagnosed with primary arterial hypertension and undergoing outpatient follow-up Receives: Other: This is a cross-sectional observational study | |
| Resistant Hypertension | Participants diagnosed with primary arterial hypertension using 3 or more antihypertensive medications, one of which is preferably a thiazide diuretic Receives: Other: This is a cross-sectional observational study | |
| Refractory Hypertension | Participants diagnosed with primary arterial hypertension using 5 or more antihypertensive medications. Receives: Other: This is a cross-sectional observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
through MAPA using non-linear calculations from Chaos Theory
Measured: 4 weeks
Heart Rate
through MAPA using non-linear calculations from Chaos Theory
Measured: 4 weeks
Level of TNF-α
Analysis of inflammatory responses associated with blood pressure variability
Measured: 10 weeks
Level of IL1β, IL-6
Analysis of inflammatory responses associated with blood pressure variability
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start27 Aug 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Tatiane De Azevedo Rubio, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450327
- Sponsor's protocol ID
- 57573922.0.0000.5415
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no data sharing.
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 30354828Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension. 2011 Jun;57(6):1076-80. doi: 10.1161/HYPERTENSIONAHA.111.170308. Epub 2011 Apr 18.
PubMed 21502568Modolo R, de Faria AP, Sabbatini AR, Barbaro NR, Ritter AM, Moreno H. Refractory and resistant hypertension: characteristics and differences observed in a specialized clinic. J Am Soc Hypertens. 2015 May;9(5):397-402. doi: 10.1016/j.jash.2015.03.005. Epub 2015 Mar 19.
PubMed 25979412Modolo R, de Faria AP, Almeida A, Moreno H. Resistant or refractory hypertension: are they different? Curr Hypertens Rep. 2014 Oct;16(10):485. doi: 10.1007/s11906-014-0485-1.
PubMed 25139782Gaddam KK, Nishizaka MK, Pratt-Ubunama MN, Pimenta E, Aban I, Oparil S, Calhoun DA. Characterization of resistant hypertension: association between resistant hypertension, aldosterone, and persistent intravascular volume expansion. Arch Intern Med. 2008 Jun 9;168(11):1159-64. doi: 10.1001/archinte.168.11.1159.
PubMed 18541823Martins LC, Figueiredo VN, Quinaglia T, Boer-Martins L, Yugar-Toledo JC, Martin JF, Demacq C, Pimenta E, Calhoun DA, Moreno H Jr. Characteristics of resistant hypertension: ageing, body mass index, hyperaldosteronism, cardiac hypertrophy and vascular stiffness. J Hum Hypertens. 2011 Sep;25(9):532-8. doi: 10.1038/jhh.2010.95. Epub 2010 Oct 7.
PubMed 20927128Figueiredo VN, Yugar-Toledo JC, Martins LC, Martins LB, de Faria AP, de Haro Moraes C, Sierra C, Coca A, Moreno H. Vascular stiffness and endothelial dysfunction: Correlations at different levels of blood pressure. Blood Press. 2012 Feb;21(1):31-8. doi: 10.3109/08037051.2011.617045. Epub 2011 Oct 27.
PubMed 22029740de Faria AP, Modolo R, Fontana V, Moreno H. Adipokines: novel players in resistant hypertension. J Clin Hypertens (Greenwich). 2014 Oct;16(10):754-9. doi: 10.1111/jch.12399. Epub 2014 Sep 4.
PubMed 25186286Barbaro NR, de Araujo TM, Tanus-Santos JE, Anhe GF, Fontana V, Moreno H. Vascular Damage in Resistant Hypertension: TNF-Alpha Inhibition Effects on Endothelial Cells. Biomed Res Int. 2015;2015:631594. doi: 10.1155/2015/631594. Epub 2015 Oct 4.
PubMed 26504819Barbaro NR, Fontana V, Modolo R, De Faria AP, Sabbatini AR, Fonseca FH, Anhe GF, Moreno H. Increased arterial stiffness in resistant hypertension is associated with inflammatory biomarkers. Blood Press. 2015 Feb;24(1):7-13. doi: 10.3109/08037051.2014.940710. Epub 2014 Jul 25.
PubMed 25061978Dudenbostel T, Siddiqui M, Oparil S, Calhoun DA. Refractory Hypertension: A Novel Phenotype of Antihypertensive Treatment Failure. Hypertension. 2016 Jun;67(6):1085-92. doi: 10.1161/HYPERTENSIONAHA.116.06587. Epub 2016 Apr 18. No abstract available.
PubMed 27091893Acelajado MC, Hughes ZH, Oparil S, Calhoun DA. Treatment of Resistant and Refractory Hypertension. Circ Res. 2019 Mar 29;124(7):1061-1070. doi: 10.1161/CIRCRESAHA.118.312156.
PubMed 30920924Acelajado MC, Pimenta E, Calhoun DA. Salt and aldosterone: a concert of bad effects. Hypertension. 2010 Nov;56(5):804-5. doi: 10.1161/HYPERTENSIONAHA.110.160960. Epub 2010 Oct 4. No abstract available.
PubMed 20921423Ritter AM, de Faria AP, Barbaro N, Sabbatini AR, Correa NB, Brunelli V, Amorim R, Modolo R, Moreno H. Crosstalk between obesity and MMP-9 in cardiac remodelling -a cross-sectional study in apparent treatment-resistant hypertension. Blood Press. 2017 Apr;26(2):122-129. doi: 10.1080/08037051.2016.1249336. Epub 2016 Nov 8.
PubMed 27825280de Haro Moraes C, Figueiredo VN, de Faria AP, Barbaro NR, Sabbatini AR, Quinaglia T, Ferreira-Melo SE, Martins LC, Demacq C, Junior HM. High-circulating leptin levels are associated with increased blood pressure in uncontrolled resistant hypertension. J Hum Hypertens. 2013 Apr;27(4):225-30. doi: 10.1038/jhh.2012.29. Epub 2012 Jul 19.
PubMed 22810172
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus")
- ClinicalTrials.gov ID
- NCT06450327
- Acronym / sponsor ID
- 57573922.0.0000.5415
- Conditions
- Hypertension, Resistant Hypertension
- Keywords
- autonomic nervous system, resistant hypertension, arterial hypertension, refractory hypertension, baroreceptors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
Resistant arterial hypertension (RAH) is a complex and multifactorial syndrome, with hyperactivity of the sympathetic nervous system (SNS) and reduction of vagal activity being considered some of the main causes of refractoriness to treatment. Seen from the outside, it resembles a complicated (see lat. "Cum plicate") or complex disease (see lat. "Cum plexus"), Chaotic with the participation of several open systems. For example, in recent years some relationships have been demonstrated between the autonomic nervous systems, synaptic mediators, hormones, inflammatory and immune responses. However, these findings have not been investigated together and systematically. In the present project, we intend to establish and compare, in an integrated way, the clinical alterations present in RAH (resistant and refractory), hemodynamic variables, autonomous activity (sympathetic and baroreflex) and interactions with the neuroimmune-endocrine systems. To this end, we will test the hypothesis that resistant patients have greater damage to the autonomic nervous system (ANS) associated with exacerbated systemic and hormonal inflammatory profile, including SNA mediators (noradrenaline and acetylcholinesterase). This is also intended to determine the behavior (deterministic or chaotic) of the systems evaluated (mentioned above) in volunteers with RAH. Sample and methods: The sample space (calculated) will consist of 72 individuals, being: - 18 refractory hypertensive (HRT); II- 18 resistant hypertensive patients (HRfT); III- 18 controlled hypertensive (1-2 drugs) (CAH); and IV- 18 healthy normotensive individuals. This is a prospective, double-blind study (patient and professional-technician), paired (1 X 4), in which the 72 volunteers will be evaluated by the methods set out below. We will also have the chance to observe whether resistant and refractory hypertension share the same pathophysiological bases and clinical manifestations ("deterministic-isolated or cardiovascular chaos") by analyzing the patterns of cardiovascular variability (MAPA and Holter) (SpaceLabs, USA; DynaMap, Brazil), inflammatory and hormonal mediators (ELISA) in the resistant hypertension - RHT and refratary hypertension - HfRT groups. Central pressure (CP) and arterial stiffness (pulse wave velocity, VOP) (Sphymocor, ATCor, USA) will also be assessed. Healthy normotensive (NT) and controlled hypertension (CAH) will be evaluated in an identical way to control the other groups. Perspectives: The findings will improve the clinical knowledge based on pathophysiology about Resistant Hypertension and, mainly, the bases of pharmacological treatment and with implantable devices (stimulation of baroreceptors and sympathetic denervation) used in this condition.
Detailed description
Cardiovascular Autonomic Modulation Procedures for spectral analysis of pulse interval (heart rate variability) and systolic blood pressure variability have been described in the literature41-44. Each heartbeat will be identified using a specialized algorithm implemented in Matlab MT software (MATLAB 6.0, Mathworks, USA ) and which automatically detects PAS and PAD waves. The pulse interval or R-R interval will be calculated as the difference between the start and end points of the cycle (t1-t0). The power spectral density of the PAS and R-R interval will be calculated using the Fast Fourier Transform and the Welch method over 16,384 points with a Hanning window and 50% overlap. The spectral bands evaluated for humans were defined according to literature references: very low frequency (MBF: 0.007-0.04Hz), low frequency (BF: 0.04-0.15Hz), high frequency (AF: 0. 15-0.4 Hz) and full power [130]. Baroreflex sensitivity will be inferred from the alpha index (HR BF ratio in ms2 / SBP BF ratio in mmHg).
ABPM - It will be performed with the CardioMAPA Monitor - Cardios - Brazil, with standardized measurements every 15 minutes during the waking period, and every 20 minutes during the sleeping period. The data will be considered valid when monitoring takes place for a minimum period of 21 hours with a minimum number of forty measurements during wakefulness and ten measurements during sleep.
Determination of Central Blood Pressure and Amplification Index (AIx) - The SphygmoCor CPV system (AtCor Medical, USA) is a sophisticated non-invasive diagnostic tool for clinical assessment of central blood pressure. This system derives central aortic pulse wave pressure (systolic, diastolic, and pulse) using pulse wave pressure recorded by the radial artery. Pulse wave analysis predicts parameters including PAC and indications of vascular stiffness. Measurements are made using a pressure transducer (tonometer) positioned in the required artery and then the pulse wave is recorded. Furthermore, this equipment provides information on arterial stiffness by analyzing the Augmentation Index [Amplification Index (AIx)], defined by the ratio between the pressure determined by the reflected wave and the ejection wave capable of providing information on arterial stiffness.
Assessment of Clinical Parameters - BP measurements will be taken according to the recommendations recommended by the VIII Brazilian Guidelines on Arterial Hypertension using a digital sphygmomanometer (Omron HEM-711DLX). Pulse pressure (PP) will be calculated from the difference between SBP and DBP values. All individuals will undergo ambulatory BP monitoring (ABPM) for a period of 24 hours using the Spacelabs 90217 equipment (Spacelabs Inc, Redmon, WA, USA). Patients will be instructed to maintain and record normal daily activities. The averages of SBP, DBP and PP will be evaluated.
Assessment of Biochemical and Inflammatory Parameters - Fasting blood samples will be collected and the following tests will be carried out: glucose, glycated hemoglobin A1C, total cholesterol and fractions, urea, creatinine, renin, aldosterone, cortisol, creatinine clearance and microalbuminuria. The biomarkers norepinephrine, dopamine, adrenaline, adrenocorticotropic hormones (ACTH) and cortisol, acetylcholinesterase, ultrasensitive C-reactive protein, interleukins 2, 8, 10 and 12 (IL-2, IL-8, IL-10 and IL-12) will be determined by ELISA according to the manufacturer's instructions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normotensives - apparently healthy | – | Other: This is a cross-sectional observational studyGroup of non-hypertensive participants |
| Controlled hypertension | – | Other: This is a cross-sectional observational studyParticipants diagnosed with primary arterial hypertension and undergoing outpatient follow-up |
| Resistant Hypertension | – | Other: This is a cross-sectional observational studyParticipants diagnosed with primary arterial hypertension using 3 or more antihypertensive medications, one of which is preferably a thiazide diuretic |
| Refractory Hypertension | – | Other: This is a cross-sectional observational studyParticipants diagnosed with primary arterial hypertension using 5 or more antihypertensive medications. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the Resistant Hypertension Outpatient Clinic of the HC of UNICAMP and FAMERP - Faculty of Medicine of São José do Rio Preto. During the first six months of follow-up, ambulatory BP monitoring (ABPM) and optimization of pharmacological therapy will be carried out, including strict control of treatment adherence (pill count) and dietary guidelines. Furthermore, possible causes of secondary hypertension will be investigated and excluded.
Key inclusion criteria (7 listed)
- men and women over 35 years of age diagnosed with resistant arterial hypertension (RH), in accordance with the latest international and national guidelines;
- be able to understand, verbalize and answer questions;
- agree to participate in the study and sign the Informed Consent Form;
- after clearly understanding it;
- be under regular follow-up at the UNICAMP Cardiovascular Pharmacology outpatient clinic for at least six months;
Key exclusion criteria (7 listed)
- clinical history or clinical symptoms of heart failure;
- patients with dilated cardiomyopathies, valvular heart disease, pericardial disorders;
- patients with cerebrovascular disease or peripheral arterial disease, nephropathies, liver diseases, smoking, autoimmune diseases and use of illicit substances;
- any abnormal condition that may interfere with the results of the study or the health of the volunteer, as judged by the researcher;
- women who are pregnant or intend to become pregnant;
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 |
|---|---|---|
| This is a cross-sectional observational studyThere will be no intervention in the study. | Other | Controlled hypertension, Normotensives - apparently healthy, Refractory Hypertension, Resistant Hypertension |
Primary outcome
Blood Pressure
Time frame: 4 weeks
through MAPA using non-linear calculations from Chaos Theory
Heart Rate
Time frame: 4 weeks
through MAPA using non-linear calculations from Chaos Theory
Level of TNF-α
Time frame: 10 weeks
Analysis of inflammatory responses associated with blood pressure variability
Level of IL1β, IL-6
Time frame: 10 weeks
Analysis of inflammatory responses associated with blood pressure variability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- 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 21502568Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension. 2011 Jun;57(6):1076-80. doi: 10.1161/HYPERTENSIONAHA.111.170308. Epub 2011 Apr 18.
- Background: PubMed 25979412Modolo R, de Faria AP, Sabbatini AR, Barbaro NR, Ritter AM, Moreno H. Refractory and resistant hypertension: characteristics and differences observed in a specialized clinic. J Am Soc Hypertens. 2015 May;9(5):397-402. doi: 10.1016/j.jash.2015.03.005. Epub 2015 Mar 19.
- Background: PubMed 25139782Modolo R, de Faria AP, Almeida A, Moreno H. Resistant or refractory hypertension: are they different? Curr Hypertens Rep. 2014 Oct;16(10):485. doi: 10.1007/s11906-014-0485-1.
- Background: PubMed 18541823Gaddam KK, Nishizaka MK, Pratt-Ubunama MN, Pimenta E, Aban I, Oparil S, Calhoun DA. Characterization of resistant hypertension: association between resistant hypertension, aldosterone, and persistent intravascular volume expansion. Arch Intern Med. 2008 Jun 9;168(11):1159-64. doi: 10.1001/archinte.168.11.1159.
- Background: PubMed 20927128Martins LC, Figueiredo VN, Quinaglia T, Boer-Martins L, Yugar-Toledo JC, Martin JF, Demacq C, Pimenta E, Calhoun DA, Moreno H Jr. Characteristics of resistant hypertension: ageing, body mass index, hyperaldosteronism, cardiac hypertrophy and vascular stiffness. J Hum Hypertens. 2011 Sep;25(9):532-8. doi: 10.1038/jhh.2010.95. Epub 2010 Oct 7.
- Background: PubMed 22029740Figueiredo VN, Yugar-Toledo JC, Martins LC, Martins LB, de Faria AP, de Haro Moraes C, Sierra C, Coca A, Moreno H. Vascular stiffness and endothelial dysfunction: Correlations at different levels of blood pressure. Blood Press. 2012 Feb;21(1):31-8. doi: 10.3109/08037051.2011.617045. Epub 2011 Oct 27.
- Background: PubMed 25186286de Faria AP, Modolo R, Fontana V, Moreno H. Adipokines: novel players in resistant hypertension. J Clin Hypertens (Greenwich). 2014 Oct;16(10):754-9. doi: 10.1111/jch.12399. Epub 2014 Sep 4.
- Background: PubMed 26504819Barbaro NR, de Araujo TM, Tanus-Santos JE, Anhe GF, Fontana V, Moreno H. Vascular Damage in Resistant Hypertension: TNF-Alpha Inhibition Effects on Endothelial Cells. Biomed Res Int. 2015;2015:631594. doi: 10.1155/2015/631594. Epub 2015 Oct 4.
- Background: PubMed 25061978Barbaro NR, Fontana V, Modolo R, De Faria AP, Sabbatini AR, Fonseca FH, Anhe GF, Moreno H. Increased arterial stiffness in resistant hypertension is associated with inflammatory biomarkers. Blood Press. 2015 Feb;24(1):7-13. doi: 10.3109/08037051.2014.940710. Epub 2014 Jul 25.
- Background: PubMed 27091893Dudenbostel T, Siddiqui M, Oparil S, Calhoun DA. Refractory Hypertension: A Novel Phenotype of Antihypertensive Treatment Failure. Hypertension. 2016 Jun;67(6):1085-92. doi: 10.1161/HYPERTENSIONAHA.116.06587. Epub 2016 Apr 18. No abstract available.
- Background: PubMed 30920924Acelajado MC, Hughes ZH, Oparil S, Calhoun DA. Treatment of Resistant and Refractory Hypertension. Circ Res. 2019 Mar 29;124(7):1061-1070. doi: 10.1161/CIRCRESAHA.118.312156.
- Individual participant dataSharing planned: No. There will be no data sharing.
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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.
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 Hypertension and Resistant Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Aug 2024. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TATIANE DE AZEVEDO RUBIO (+55(17)991422510, thatyazevedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 4 weeks). The study lists 4 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 NCT06450327, which also lists 48 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 29 Aug 2024.