Clinical trial NCT06764277: Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis
Official title: Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Hemodialysis
Keywords: kemodialysis,
hypertension
inflammation
renin angiotensin system
sympathetic nervous system
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paa}rticipantes will be patients in the chronic hemodialysis program of the INCMNSZ

Brief summary: 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: 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,

Eligibility criteria: 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

Primary outcomes:
measure: Determine incidence of hypertension phenotypes in patients in chronic hemodialysis
timeFrame: Studies will be done in a single opportunity in each patient (after dialysis, interdialysis period (2-3 days) and before the next dialysis. Reports through study completion, an average of 1 year
measure: Cardiac output in patients in chronic hemodialysis
timeFrame: Measures will be done once, at the end of dialysis. Reports through study completion, an average of 1 year
measure: Determine the value of peripheral vascular ressistance (dynes/cm2) at the end of dialysis
timeFrame: There will be determination at the end of dialysis. Reports through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants in the phenotypes of hypertension with interdialysis weight gain
timeFrame: Studies in 2-3 days (interdialytic period). Reports through study completion, an average of 1 year
measure: Number of participantes with increment in blood pressure and increment in angiotensin II in the interdialysis period
timeFrame: Studies done in interdialysis period (2-3 days). Reports through study completion, an average of 1 year
measure: Number of participantes with increase in blood pressure and changes in inflammatory biomarkers
timeFrame: Studies donne before and after dialysis (2-3 days interdialytic period). Reports through study completion, an average of 1 year
measure: Number of participantes that increased blood pressure and changes in norepinephrine levels
timeFrame: Studies done before and after dialysis (2-3 days interdialytic period). Reports through study completion, an average of 1 year
Other outcomes:
measure: Changes in copeptin levels in the interdialytic period (2-3 days)
timeFrame: Determinations before and after dialysis (2-3 days interdialytic period). Reports through study completion, an average of 1 year
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán"
name: Bernardo RODRIGUEZITURBE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.