Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis

NCT ID: NCT06764277

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-14

Study Completion Date

2025-06-06

Brief Summary

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The goal of this study is to evalluate the 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 hypertension of patients in chronic hemodialysis, The participantes will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period and before the next dialysis (2-3 days later). Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.

Detailed Description

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This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the INCMNSZ patients. There will be no modifications in the dialysis prescriptions and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.

* Weight (kilograms) changes will be studied after dialysis and before the next dialysis sesion (2-3 days later)
* Serum samples will be obtained at the end of dialysis and before the next sesion (2-3 days later).
* ultrasound estimation of cardiac output and peripheral vascular rersistance will be done after dialysis
* Ambulatory blood pressure monitoring will be done in the interdialytic period (24-48 hours) between the end of dialysis and the next dialysis sesion.
* If possible there will be a predialysis study of bioimpedance. Associations of weight gain (kilograms), serum angiotensin II and angiotensin 1-7 (pg/ml), levels of IL-6 (pg/ml), IL-17 (pg/ml), IL-10 (pg/ml), TNFalpha (pg/ml), copeptin levels(pg/ml) and norepinephrin levels (pg/ml) with systolic and diastolic blood pressure (mmHg) 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) hypertension determined by ambulatory monitoring will be studied in relation of levels of angiotensin II, immune inflammatory markers, copeptin and norepinephrin leves.

All serum levels will be determined by commercial ELISA kits,

Conditions

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Arterial Hypertension Hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

-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

Exclusion Criteria

* Patiens unable to give informed consent to the study
* Patients with active infection
* Patients with prostesis or pacemakers
* Patients with immunosuppresive treatment equivalent to more than 15mg Prednisone daily
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernardo Rodríguez Iturbe

OTHER

Sponsor Role lead

Responsible Party

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Bernardo Rodríguez Iturbe

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bernardo RODRIGUEZITURBE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán"

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 26644240 (View on PubMed)

Fay 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.

Reference Type BACKGROUND
PMID: 32712185 (View on PubMed)

Abais-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.

Reference Type BACKGROUND
PMID: 26125645 (View on PubMed)

Agarwal 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.

Reference Type BACKGROUND
PMID: 20507951 (View on PubMed)

Rodriguez-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.

Reference Type BACKGROUND
PMID: 28566539 (View on PubMed)

Neumann 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.

Reference Type BACKGROUND
PMID: 15086894 (View on PubMed)

Kim 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.

Reference Type BACKGROUND
PMID: 4561117 (View on PubMed)

Buckalew 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.

Reference Type BACKGROUND
PMID: 8957032 (View on PubMed)

Saad 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.

Reference Type BACKGROUND
PMID: 15250921 (View on PubMed)

Other Identifiers

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NMM-4512-23-24-1

Identifier Type: -

Identifier Source: org_study_id

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