Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus") Syndrome?

NCT06450327 | Recruiting DMC

• 1 other identifier: 57573922.0.0000.5415
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Resistant arterial hypertension (RAH) is a complex and multifactorial syndrome, with hyperactivity of the sympathetic nervous system (SNS) and reduction of vagal activity being considered some of the main causes of refractoriness to treatment. Seen from the outside, it resembles a complicated (see lat. "Cum plicate") or complex disease (see lat. "Cum plexus"), Chaotic with the participation of several open systems. For example, in recent years some relationships have been demonstrated between the autonomic nervous systems, synaptic mediators, hormones, inflammatory and immune responses. However, these findings have not been investigated together and systematically. In the present project, we intend to establish and compare, in an integrated way, the clinical alterations present in RAH (resistant and refractory), hemodynamic variables, autonomous activity (sympathetic and baroreflex) and interactions with the neuroimmune-endocrine systems. To this end, we will test the hypothesis that resistant patients have greater damage to the autonomic nervous system (ANS) associated with exacerbated systemic and hormonal inflammatory profile, including SNA mediators (noradrenaline and acetylcholinesterase). This is also intended to determine the behavior (deterministic or chaotic) of the systems evaluated (mentioned above) in volunteers with RAH. Sample and methods: The sample space (calculated) will consist of 72 individuals, being: - 18 refractory hypertensive (HRT); II- 18 resistant hypertensive patients (HRfT); III- 18 controlled hypertensive (1-2 drugs) (CAH); and IV- 18 healthy normotensive individuals. This is a prospective, double-blind study (patient and professional-technician), paired (1 X 4), in which the 72 volunteers will be evaluated by the methods set out below. We will also have the chance to observe whether resistant and refractory hypertension share the same pathophysiological bases and clinical manifestations ("deterministic-isolated or cardiovascular chaos") by analyzing the patterns of cardiovascular variability (MAPA and Holter) (SpaceLabs, USA; DynaMap, Brazil), inflammatory and hormonal mediators (ELISA) in the resistant hypertension - RHT and refratary hypertension - HfRT groups. Central pressure (CP) and arterial stiffness (pulse wave velocity, VOP) (Sphymocor, ATCor, USA) will also be assessed. Healthy normotensive (NT) and controlled hypertension (CAH) will be evaluated in an identical way to control the other groups. Perspectives: The findings will improve the clinical knowledge based on pathophysiology about Resistant Hypertension and, mainly, the bases of pharmacological treatment and with implantable devices (stimulation of baroreceptors and sympathetic denervation) used in this condition.

Conditions

Hypertension; Resistant Hypertension

Keywords

autonomic nervous system; resistant hypertension; arterial hypertension; refractory hypertension; baroreceptors

Outcome Measures

Primary Outcomes (4)

• Blood Pressure

  through MAPA using non-linear calculations from Chaos Theory

  4 weeks

• Heart Rate

  through MAPA using non-linear calculations from Chaos Theory

  4 weeks

• Level of TNF-α

  Analysis of inflammatory responses associated with blood pressure variability

  10 weeks

• Level of IL1β, IL-6

  Analysis of inflammatory responses associated with blood pressure variability

  10 weeks

Study Arms (4)

Normotensives - apparently healthy

Group of non-hypertensive participants

Other: This is a cross-sectional observational study

Controlled hypertension

Participants diagnosed with primary arterial hypertension and undergoing outpatient follow-up

Other: This is a cross-sectional observational study

Resistant Hypertension

Participants diagnosed with primary arterial hypertension using 3 or more antihypertensive medications, one of which is preferably a thiazide diuretic

Other: This is a cross-sectional observational study

Refractory Hypertension

Participants diagnosed with primary arterial hypertension using 5 or more antihypertensive medications.

Other: This is a cross-sectional observational study

Interventions

This is a cross-sectional observational study OTHER

There will be no intervention in the study.

Controlled hypertension; Normotensives - apparently healthy; Refractory Hypertension; Resistant Hypertension

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from the Resistant Hypertension Outpatient Clinic of the HC of UNICAMP and FAMERP - Faculty of Medicine of São José do Rio Preto. During the first six months of follow-up, ambulatory BP monitoring (ABPM) and optimization of pharmacological therapy will be carried out, including strict control of treatment adherence (pill count) and dietary guidelines. Furthermore, possible causes of secondary hypertension will be investigated and excluded.

You may qualify if:

• men and women over 35 years of age diagnosed with resistant arterial hypertension (RH), in accordance with the latest international and national guidelines;
• be able to understand, verbalize and answer questions;
• agree to participate in the study and sign the Informed Consent Form;
• after clearly understanding it;
• be under regular follow-up at the UNICAMP Cardiovascular Pharmacology outpatient clinic for at least six months;
• have proven adherence to non-pharmacological and pharmacological treatment;
• women in the reproductive phase must be using a proven effective contraceptive method.

You may not qualify if:

• clinical history or clinical symptoms of heart failure;
• patients with dilated cardiomyopathies, valvular heart disease, pericardial disorders;
• patients with cerebrovascular disease or peripheral arterial disease, nephropathies, liver diseases, smoking, autoimmune diseases and use of illicit substances;
• any abnormal condition that may interfere with the results of the study or the health of the volunteer, as judged by the researcher;
• women who are pregnant or intend to become pregnant;
• current participation in another investigative study;
• major depression or other relevant psychiatric disorders.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Tatiane de Azevedo Rubio

Votuporanga, São Paulo, 15505185, Brazil

RECRUITING

Related Publications (48)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

TATIANE DE AZEVEDO RUBIO

CONTACT

+55(17)991422510; thatyazevedo@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: August 27, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)