What is this study trying to find out about resistant hypertension?

This study aims to explore the clinical and biological changes in resistant and refractory hypertension, focusing on the autonomic nervous system and inflammatory profiles. Researchers want to understand how these complex conditions differ or overlap in their causes and effects. The study is sponsored by the University of Campinas, Brazil, to improve knowledge about resistant hypertension.

Who may be eligible for this hypertension clinical trial?

Adults aged 35 to 85 diagnosed with resistant arterial hypertension and under regular cardiovascular follow-up may be eligible. Participants must understand the study, adhere to treatments, and women of reproductive age need effective contraception. People with heart failure or severe psychiatric disorders are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this hypertension clinical trial?

Study-related care, including all assessments and monitoring, is provided at no cost. However, personal expenses such as travel or accommodations are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Age: 18Years - 85Years

All Genders

Healthy Volunteers

ID06450327

Study of Resistant and Refractory Hypertension to Understand Its Complex Causes and Effects on the Nervous and Immune Systems

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

Participants Needed

Research Sites

34 weeks

Total Duration

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- 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 hypertensions 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

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

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

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