RecruitingNCT06450327

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

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


Sponsor

University of Campinas, Brazil

Enrollment

80 participants

Start Date

Aug 27, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study investigates resistant hypertension — high blood pressure that stays elevated despite taking 3 or more medications — to better understand its complexity and whether it involves multiple interacting conditions or a single difficult-to-treat syndrome. **You may be eligible if...** - You are 35 or older - You have been diagnosed with resistant arterial hypertension per current guidelines - You have been followed regularly at the UNICAMP Cardiovascular Pharmacology outpatient clinic for at least 6 months - You have demonstrated adherence to both medication and lifestyle changes **You may NOT be eligible if...** - You have a history or symptoms of heart failure - You are pregnant or using unreliable contraception (if of reproductive age) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERThis is a cross-sectional observational study

There will be no intervention in the study.


Locations(1)

Tatiane de Azevedo Rubio

Votuporanga, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06450327


Related Trials