Arterial HypertensionNCT06764277
Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis
An observational study of Arterial Hypertension and Hemodialysis, run by Bernardo Rodríguez Iturbe at 1 site in Mexico.
Trial summary
The goal of this study is to evaluate interdialytic blood pressure changes of the patients in chronic hemodialysis. The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the interdialytic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Hemodialysis
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 14 Aug 2023to 6 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participantes will be patients in the chronic hemodialysis program of the INCMNSZ assigned to the groups depending on the ambulatory blood pressure (ABP) monitoring: Group A (TA < 130/80 mmHg), group B (TA 130-139/80-89 mmHg and group C (TA > 140mmHg)
Who may be able to join
- Patients with more than 3 months in the chronic hemodialysis program in the INCMNSZ and assumed to remained in the program for longer than 3 months
- Stable patients with no change in medication 1 month prior to the study
- Unchanged drug therapy and dialysis prescription for >1 month prior to the studies
- Informed consent to participate in the study
Who cannot join
- Patients unable to give informed consent or withdrawal of informed consent to the study
- Patients with active infection
- Patients with prosthesis or pacemakers
- Patients with immunosuppressive treatment of more than 10mg Prednisone daily
- Prior nephrectomy
- incomplete collection of data specified in the study protocol
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, 14080
About this study
The goal of this study is to evaluate interdialytic blood pressure changes of the patients in chronic hemodialysis.
The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the interdialytic hypertension of patients in chronic hemodialysis, The participants will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period. Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.
Read the detailed description
This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" (INCMNSZ) patients. There will be no modifications in the dialysis prescriptions or treatments and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.
- Weight changes will be studied after dialysis and before the next dialysis session (2-3 days later)
- Serum samples will be obtained at the end of dialysis and before the next session (2-3 days later).
- ultrasound estimation of cardiac output and peripheral vascular rersistance will be done after dialysis
- Ambulatory blood pressure (ABP) monitoring will be done in the interdialytic period (24-40 hours) between the end of dialysis and the next dialysis session.
- If possible there will be a predialysis study of bioimpedance.
- Associations of interdialytic weight gain, serum angiotensin II, copeptin levels (surrogate of arginine vasopressin) and norepinephrine levels with ABP, systolic and diastolic blood pressure before and after dialysis will be explored.
- Phenotypes of blood pressure (sustained hypertension, nocturnal and diurnal hypertension, dippers, non-dippers, extreme dippers and reverse dippers) determined by ambulatory monitoring will be studied in relation of levels of angiotensin II, inflammatory markers, copeptin and norepinephrine levels.
All serum levels will be determined by commercial ELISA kits
- Conditions
- Arterial Hypertension, Hemodialysis
- Being tested
- There will be no intervention
- Keywords
- hemodialysis, hypertension, inflammation, renin angiotensin system, sympathetic nervous system, interdialysis, Interdialytic weight gain
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There will be no interventionOther
There will be no intervention. This is an observational studies and 3 groups will be organized depending on the level of ABP in the interdialytic period
| Study group | Role | What they receive |
|---|---|---|
| Group A | There will be no intervention. Group A will be patients with ABP (ambulatory blood pressure) <130/80 mmHg (controlled hypertension) Receives: Other: There will be no intervention | |
| Group B | There will be no intervention. Group B will be patients with ABP 130-139/80-89 mmHg (insufficiently controled hypertension) Receives: Other: There will be no intervention | |
| Group C | There will be no intervention. Group C will be patients with ABP ≥140/90 mmHg (uncontrolled hypertension) Receives: Other: There will be no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Measured: Each participant was studied once 1-3 hours after dialysis ended
Interdialytic Weight Change
The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure.
Measured: Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis.
Systemic Vascular Resistance
Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=[(MAP-CVP)x79.92]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Measured: Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis
Secondary outcomes (5)
Angiotensin II Serum Levels
Angiotensin serum levels (pg/ml) were determined once at the end of the interdialytic period, before dialysis, using ELISA (my BioSource Cat.# MBS703599)
Measured: Each participant was studied once. Serum samples taken before dialysis
Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR)
Monocyte+Neutrophile/lymphocyte ratio obtained from peripheral blood counts in samples taken before dialysis (following the end of the interdialytic period).
Measured: Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period).
Serum Norepinephrine Levels
Interdialytic serum norepinephrine levels determined in blood samples obtained before dialysis (end of interdialytic period) using ELISA (ABCAM, Cat. # AB287789);
Measured: Each participant was studied once. Serum samples taken before dialysis
Serum Copeptin Levels
The copeptin levels (surrogate for arginine vasopressin) were measured before dialyisis (end of the interdialytic period) using ELISA (Bio-techne/NovusBiological, Cat, # NBP2-69822)
Measured: Each participant was studied once. Serum samples taken before dialysis
Hypertension Phenotypes
Interdialytic ambulatory blood pressure determined during 24-44 hours using Space Labs Health Care, model 90217A and Contec ABPM50 equipment. Determinations every 30 minutes during daytime and every hour during the night. We are here reporting the phenotypes in the total number of participants (n=32) instead that in each group (groups A n=15, B n=7 and C n=10) because our main interest was to determine the incidence of each phenotyte in stable patients treated with chronic dialysis, rather than in each group that, individually, had few patients
Measured: Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start14 Aug 2023
- Primary completion20 Dec 2024
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arterial 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernardo Rodríguez Iturbe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernardo Rodríguez Iturbe, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Bernardo RODRIGUEZITURBE, MD, PhD, Principal investigator, Department of Nephrology, Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764277
- Sponsor's protocol ID
- NMM-4512-23-24-1
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2024
- Last updated
- 3 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez-Iturbe B. Autoimmunity in the Pathogenesis of Hypertension. Hypertension. 2016 Mar;67(3):477-83. doi: 10.1161/HYPERTENSIONAHA.115.06418. Epub 2015 Dec 7. No abstract available.
PubMed 26644240Fay KS, Cohen DL. Resistant Hypertension in People With CKD: A Review. Am J Kidney Dis. 2021 Jan;77(1):110-121. doi: 10.1053/j.ajkd.2020.04.017. Epub 2020 Jul 23.
PubMed 32712185Abais-Battad JM, Rudemiller NP, Mattson DL. Hypertension and immunity: mechanisms of T cell activation and pathways of hypertension. Curr Opin Nephrol Hypertens. 2015 Sep;24(5):470-4. doi: 10.1097/MNH.0000000000000146.
PubMed 26125645Agarwal R, Weir MR. Dry-weight: a concept revisited in an effort to avoid medication-directed approaches for blood pressure control in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Jul;5(7):1255-60. doi: 10.2215/CJN.01760210. Epub 2010 May 27.
PubMed 20507951Rodriguez-Iturbe B, Pons H, Johnson RJ. Role of the Immune System in Hypertension. Physiol Rev. 2017 Jul 1;97(3):1127-1164. doi: 10.1152/physrev.00031.2016.
PubMed 28566539Neumann J, Ligtenberg G, Klein II, Koomans HA, Blankestijn PJ. Sympathetic hyperactivity in chronic kidney disease: pathogenesis, clinical relevance, and treatment. Kidney Int. 2004 May;65(5):1568-76. doi: 10.1111/j.1523-1755.2004.00552.x.
PubMed 15086894Kim KE, Onesti G, Schwartz AB, Chinitz JL, Swartz C. Hemodynamics of hypertension in chronic end-stage renal disease. Circulation. 1972 Sep;46(3):456-64. doi: 10.1161/01.cir.46.3.456. No abstract available.
PubMed 4561117Buckalew VM Jr, Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am J Kidney Dis. 1996 Dec;28(6):811-21. doi: 10.1016/s0272-6386(96)90380-7.
PubMed 8957032Saad E, Charra B, Raj DS. Hypertension control with daily dialysis. Semin Dial. 2004 Jul-Aug;17(4):295-8. doi: 10.1111/j.0894-0959.2004.17330.x.
PubMed 15250921
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT06764277
- Acronym / sponsor ID
- NMM-4512-23-24-1
- Conditions
- Arterial Hypertension, Hemodialysis
- Keywords
- hemodialysis, hypertension, inflammation, renin angiotensin system, sympathetic nervous system, interdialysis, Interdialytic weight gain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bernardo Rodríguez IturbeUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate interdialytic blood pressure changes of the patients in chronic hemodialysis.
The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the interdialytic hypertension of patients in chronic hemodialysis, The participants will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period. Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.
Detailed description
This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" (INCMNSZ) patients. There will be no modifications in the dialysis prescriptions or treatments and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.
- Weight changes will be studied after dialysis and before the next dialysis session (2-3 days later)
- Serum samples will be obtained at the end of dialysis and before the next session (2-3 days later).
- ultrasound estimation of cardiac output and peripheral vascular rersistance will be done after dialysis
- Ambulatory blood pressure (ABP) monitoring will be done in the interdialytic period (24-40 hours) between the end of dialysis and the next dialysis session.
- If possible there will be a predialysis study of bioimpedance.
- Associations of interdialytic weight gain, serum angiotensin II, copeptin levels (surrogate of arginine vasopressin) and norepinephrine levels with ABP, systolic and diastolic blood pressure before and after dialysis will be explored.
- Phenotypes of blood pressure (sustained hypertension, nocturnal and diurnal hypertension, dippers, non-dippers, extreme dippers and reverse dippers) determined by ambulatory monitoring will be studied in relation of levels of angiotensin II, inflammatory markers, copeptin and norepinephrine levels.
All serum levels will be determined by commercial ELISA kits
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: There will be no interventionThere will be no intervention. Group A will be patients with ABP (ambulatory blood pressure) <130/80 mmHg (controlled hypertension) |
| Group B | – | Other: There will be no interventionThere will be no intervention. Group B will be patients with ABP 130-139/80-89 mmHg (insufficiently controled hypertension) |
| Group C | – | Other: There will be no interventionThere will be no intervention. Group C will be patients with ABP ≥140/90 mmHg (uncontrolled hypertension) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participantes will be patients in the chronic hemodialysis program of the INCMNSZ assigned to the groups depending on the ambulatory blood pressure (ABP) monitoring: Group A (TA < 130/80 mmHg), group B (TA 130-139/80-89 mmHg and group C (TA > 140mmHg)
Key inclusion criteria (4 listed)
- Patients with more than 3 months in the chronic hemodialysis program in the INCMNSZ and assumed to remained in the program for longer than 3 months
- Stable patients with no change in medication 1 month prior to the study
- Unchanged drug therapy and dialysis prescription for >1 month prior to the studies
- Informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patients unable to give informed consent or withdrawal of informed consent to the study
- Patients with active infection
- Patients with prosthesis or pacemakers
- Patients with immunosuppressive treatment of more than 10mg Prednisone daily
- Prior nephrectomy
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 |
|---|---|---|
| There will be no interventionThere will be no intervention. This is an observational studies and 3 groups will be organized depending on the level of ABP in the interdialytic period | Other | Group A, Group B, Group C |
Primary outcome
Cardiac Output
Time frame: Each participant was studied once 1-3 hours after dialysis ended
Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Interdialytic Weight Change
Time frame: Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis.
The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure.
Systemic Vascular Resistance
Time frame: Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis
Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=[(MAP-CVP)x79.92]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
5 secondary outcomes
Angiotensin II Serum Levels
Time frame: Each participant was studied once. Serum samples taken before dialysis
Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR)
Time frame: Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period).
Serum Norepinephrine Levels
Time frame: Each participant was studied once. Serum samples taken before dialysis
Serum Copeptin Levels
Time frame: Each participant was studied once. Serum samples taken before dialysis
Hypertension Phenotypes
Time frame: Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26644240Rodriguez-Iturbe B. Autoimmunity in the Pathogenesis of Hypertension. Hypertension. 2016 Mar;67(3):477-83. doi: 10.1161/HYPERTENSIONAHA.115.06418. Epub 2015 Dec 7. No abstract available.
- Background: PubMed 32712185Fay KS, Cohen DL. Resistant Hypertension in People With CKD: A Review. Am J Kidney Dis. 2021 Jan;77(1):110-121. doi: 10.1053/j.ajkd.2020.04.017. Epub 2020 Jul 23.
- Background: PubMed 26125645Abais-Battad JM, Rudemiller NP, Mattson DL. Hypertension and immunity: mechanisms of T cell activation and pathways of hypertension. Curr Opin Nephrol Hypertens. 2015 Sep;24(5):470-4. doi: 10.1097/MNH.0000000000000146.
- Background: PubMed 20507951Agarwal R, Weir MR. Dry-weight: a concept revisited in an effort to avoid medication-directed approaches for blood pressure control in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Jul;5(7):1255-60. doi: 10.2215/CJN.01760210. Epub 2010 May 27.
- Background: PubMed 28566539Rodriguez-Iturbe B, Pons H, Johnson RJ. Role of the Immune System in Hypertension. Physiol Rev. 2017 Jul 1;97(3):1127-1164. doi: 10.1152/physrev.00031.2016.
- Background: PubMed 15086894Neumann J, Ligtenberg G, Klein II, Koomans HA, Blankestijn PJ. Sympathetic hyperactivity in chronic kidney disease: pathogenesis, clinical relevance, and treatment. Kidney Int. 2004 May;65(5):1568-76. doi: 10.1111/j.1523-1755.2004.00552.x.
- Background: PubMed 4561117Kim KE, Onesti G, Schwartz AB, Chinitz JL, Swartz C. Hemodynamics of hypertension in chronic end-stage renal disease. Circulation. 1972 Sep;46(3):456-64. doi: 10.1161/01.cir.46.3.456. No abstract available.
- Background: PubMed 8957032Buckalew VM Jr, Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am J Kidney Dis. 1996 Dec;28(6):811-21. doi: 10.1016/s0272-6386(96)90380-7.
- Background: PubMed 15250921Saad E, Charra B, Raj DS. Hypertension control with daily dialysis. Semin Dial. 2004 Jul-Aug;17(4):295-8. doi: 10.1111/j.0894-0959.2004.17330.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardo RODRIGUEZITURBE, MD, PhD principal investigator
Department of Nephrology, Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán"
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 Arterial Hypertension and Hemodialysis, run by Bernardo Rodríguez Iturbe at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 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 3 Feb 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiac Output (time frame: Each participant was studied once 1-3 hours after dialysis ended). The study lists 3 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 NCT06764277, which also lists 9 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 3 Feb 2026.