Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID06450327

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

Led by University of Campinas, Brazil · Updated on 2024-08-29

80

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

U

University of Campinas, Brazil

Lead Sponsor

F

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating resistant arterial hypertension (RAH), a complex condition involving overactive sympathetic nervous system activity and reduced vagal function, which contributes to treatment resistance. This study aims to compare clinical changes, hemodynamic variables, autonomic nervous system activity, and interactions with neuroimmune-endocrine systems in resistant and refractory hypertension. The project will explore whether these conditions share similar pathophysiological bases and manifestations through detailed cardiovascular variability and inflammatory mediator analyses. This observational study involves 72 volunteers divided into four groups: refractory hypertensive, resistant hypertensive, controlled hypertensive, and healthy normotensive individuals. Each participant will undergo various assessments including ambulatory blood pressure monitoring, heart rate variability analysis, central blood pressure and arterial stiffness measurements, and blood tests for biochemical and inflammatory markers. Advanced equipment and software will be used to evaluate pulse wave analysis, baroreflex sensitivity, and inflammatory and hormonal profiles. Participants will have their blood pressure and heart rate monitored over several weeks, with inflammatory markers like TNF-α and interleukins evaluated at 10 weeks. Clinical parameters will be measured using digital sphygmomanometers and ambulatory monitors, while fasting blood samples will assess glucose, cholesterol, and various hormones. The study will also assess adherence to treatment and monitor cardiovascular variability, aiming to improve understanding of resistant hypertension's pathophysiology and guide future pharmacological and device-based treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women over 35 years diagnosed with resistant arterial hypertension according to guidelines
  • Ability to understand and answer questions
  • Willingness to participate and sign informed consent
  • Under regular follow-up at the UNICAMP Cardiovascular Pharmacology outpatient clinic for at least six months
  • Proven adherence to non-pharmacological and pharmacological treatment
  • Women in reproductive phase must use effective contraception
Not Eligible

You will not qualify if you...

  • History or symptoms of heart failure
  • Presence of dilated cardiomyopathies, valvular heart disease, or pericardial disorders
  • Cerebrovascular disease, peripheral arterial disease, nephropathies, liver diseases, autoimmune diseases, smoking, or illicit substance use
  • Any condition interfering with study results or participant health as judged by researcher
  • Pregnant women or those intending pregnancy
  • Participation in another investigative study
  • Major depression or other significant psychiatric disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 10 weeks

Participants undergo various cardiovascular and biochemical assessments including blood pressure monitoring, heart rate variability analysis, central blood pressure measurement, and blood sample collection to evaluate biochemical and inflammatory markers.

1 to 2 visits depending on assessment requirements

Long-term Monitoring

Duration - 4 to 10 weeks

Participants are observed over time to evaluate blood pressure, heart rate, and inflammatory markers as part of the study outcomes.

Follow-up assessments may occur depending on outcome measures timing

Trial Site Locations

Total: 1 location

1

Tatiane de Azevedo Rubio

Votuporanga, São Paulo, Brazil, 15505185

Actively Recruiting

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Research Team

T

TATIANE DE AZEVEDO RUBIO

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association.

Robert M Carey, David A Calhoun, George L Bakris...

https://pubmed.ncbi.nlm.nih.gov/30354828

Refractory and resistant hypertension: characteristics and differences observed in a specialized clinic.

Rodrigo Modolo, Ana Paula de Faria, Andréa Rodrigues Sabbatini...

https://pubmed.ncbi.nlm.nih.gov/25979412

Characterization of resistant hypertension: association between resistant hypertension, aldosterone, and persistent intravascular volume expansion.

Krishna K Gaddam, Mari K Nishizaka, Monique N Pratt-Ubunama...

https://pubmed.ncbi.nlm.nih.gov/18541823

Characteristics of resistant hypertension: ageing, body mass index, hyperaldosteronism, cardiac hypertrophy and vascular stiffness.

L C Martins, V N Figueiredo, T Quinaglia...

https://pubmed.ncbi.nlm.nih.gov/20927128

Vascular stiffness and endothelial dysfunction: Correlations at different levels of blood pressure.

Valéria Nasser Figueiredo, Juan Carlos Yugar-Toledo, Luiz Cláudio Martins...

https://pubmed.ncbi.nlm.nih.gov/22029740

Vascular Damage in Resistant Hypertension: TNF-Alpha Inhibition Effects on Endothelial Cells.

Natália Ruggeri Barbaro, Thiago Matos de Araújo, José Eduardo Tanus-Santos...

https://pubmed.ncbi.nlm.nih.gov/26504819