Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis

Active, not recruiting

• Conditions: Arterial Hypertension; Hemodialysis

• Registration Number: NCT06764277
• Lead Sponsor: Bernardo Rodríguez Iturbe

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,

Study Timeline

• Study Start: 2023-08-14
• Study First Submitted: 2024-12-19
• Primary Completion: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine incidence of hypertension phenotypes in patients in chronic hemodialysis	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	The number of participants with sustained, nocturnal, diurnal, dipping, non dipping and reverse dipping hypertension
Cardiac output in patients in chronic hemodialysis	Measures will be done once, at the end of dialysis. Reports through study completion, an average of 1 year	The cardiac output (liters/min) will be determined by ultrasound methodology after dialysis to determine their relation to blood pressure
Determine the value of peripheral vascular ressistance (dynes/cm2) at the end of dialysis	There will be determination at the end of dialysis. Reports through study completion, an average of 1 year	Peripheral vascular resistance (dynes/cm2) will be determined at the end of dialysis by ultrasound determinations of cardiac output and central venous pressure

Secondary Outcome Measures

Name	Time	Method
Number of participants in the phenotypes of hypertension with interdialysis weight gain	Studies in 2-3 days (interdialytic period). Reports through study completion, an average of 1 year	The change of post-dialysis (dry weight, kg) to predialysis weight (water retention, kg) will be evaluated in relation to changes in blood pressure
Number of participantes with increment in blood pressure and increment in angiotensin II in the interdialysis period	Studies done in interdialysis period (2-3 days). Reports through study completion, an average of 1 year	Blood pressure will be measured at the end of dialysis and at the beginning of the next dialysis (2-3 days later) and related to the changes in the serum levels of angiotensin II and angiotensin 1-7(pg/ml).
Number of participantes with increase in blood pressure and changes in inflammatory biomarkers	Studies donne before and after dialysis (2-3 days interdialytic period). Reports through study completion, an average of 1 year	The changes in blood pressure will be studied in relation to the changes in the levels levels of IL-6, IL-2, IL-17, IL-10 and TNFalpha ( pg/ml)
Number of participantes that increased blood pressure and changes in norepinephrine levels	Studies done before and after dialysis (2-3 days interdialytic period). Reports through study completion, an average of 1 year	The change in blood pressure between the end of one dialysis and the beginning of the next (2-3 days later) will be analyzed in relation to the changes in serum norepinephrine levels (pg/ml)

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"; 🇲🇽 Mexico City, Mexico