Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis

NCT06764277 | Completed Results DMC

• 1 other identifier: NMM-4512-23-24-1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Arterial Hypertension; Hemodialysis

Keywords

hemodialysis; hypertension; inflammation; renin angiotensin system; sympathetic nervous system; interdialysis; Interdialytic weight gain

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis

Secondary Outcomes (5)

• Angiotensin II Serum Levels

  Each participant was studied once. Serum samples taken before dialysis

• Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR)

  Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period).

• Serum Norepinephrine Levels

  Each participant was studied once. Serum samples taken before dialysis

• Serum Copeptin Levels

  Each participant was studied once. Serum samples taken before dialysis

• Hypertension Phenotypes

  Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis

Study Arms (3)

Group A

There will be no intervention. Group A will be patients with ABP (ambulatory blood pressure) \<130/80 mmHg (controlled hypertension)

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)

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)

Other: There will be no intervention

Interventions

There will be no intervention OTHER

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernardo Rodríguez Iturbe: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14080, Mexico

Location

Related Publications (9)

• 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.

  PMID: 26644240 BACKGROUND

• 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.

  PMID: 32712185 BACKGROUND

• 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.

  PMID: 26125645 BACKGROUND

• 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.

  PMID: 20507951 BACKGROUND

• 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.

  PMID: 28566539 BACKGROUND

• 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.

  PMID: 15086894 BACKGROUND

• 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.

  PMID: 4561117 BACKGROUND

• 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.

  PMID: 8957032 BACKGROUND

• 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.

  PMID: 15250921 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples: Serum levels of angiotensin II, norepinephrine, copeptin, Peripheral blood: Ratio of monocytes + neutrophils / lymphocytes (MNLR).

MeSH Terms

Conditions

Hypertension; Inflammation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1\) Potential effects of antihypertension drug therapy (observational study) may not be completely discarded. 2)Only 32 patients in only one recruitment center. Further studies are required to validate the results.

Results Point of Contact

• Title: Dr. Bernardo Rodriguez Iturbe
• Organization: Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran"

brodrigueziturbe@gmail.com

9991490061

Study Officials

• Bernardo RODRIGUEZITURBE, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 8, 2025
• Study Start: August 14, 2023
• Primary Completion: December 20, 2024
• Study Completion: June 6, 2025
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)