Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450327
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
Resistant Hypertension An Open Complicated Cum Plicare or Complex Cum Plexus Syndrome
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
Resistant Hypertension An Open Complicated Cum Plicare or Complex Cum Plexus
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cardiovascular Autonomic Modulation Procedures for spectral analysis of pulse interval heart rate variability and systolic blood pressure variability have been described in the literature41-44 Each heartbeat will be identified using a specialized algorithm implemented in Matlab MT software MATLAB 60 Mathworks USA and which automatically detects PAS and PAD waves The pulse interval or R-R interval will be calculated as the difference between the start and end points of the cycle t1-t0 The power spectral density of the PAS and R-R interval will be calculated using the Fast Fourier Transform and the Welch method over 16384 points with a Hanning window and 50 overlap The spectral bands evaluated for humans were defined according to literature references very low frequency MBF 0007-004Hz low frequency BF 004-015Hz high frequency AF 0 15-04 Hz and full power 130 Baroreflex sensitivity will be inferred from the alpha index HR BF ratio in ms2 SBP BF ratio in mmHg
ABPM - It will be performed with the CardioMAPA Monitor - Cardios - Brazil with standardized measurements every 15 minutes during the waking period and every 20 minutes during the sleeping period The data will be considered valid when monitoring takes place for a minimum period of 21 hours with a minimum number of forty measurements during wakefulness and ten measurements during sleep
Determination of Central Blood Pressure and Amplification Index AIx - The SphygmoCor CPV system AtCor Medical USA is a sophisticated non-invasive diagnostic tool for clinical assessment of central blood pressure This system derives central aortic pulse wave pressure systolic diastolic and pulse using pulse wave pressure recorded by the radial artery Pulse wave analysis predicts parameters including PAC and indications of vascular stiffness Measurements are made using a pressure transducer tonometer positioned in the required artery and then the pulse wave is recorded Furthermore this equipment provides information on arterial stiffness by analyzing the Augmentation Index Amplification Index AIx defined by the ratio between the pressure determined by the reflected wave and the ejection wave capable of providing information on arterial stiffness
Assessment of Clinical Parameters - BP measurements will be taken according to the recommendations recommended by the VIII Brazilian Guidelines on Arterial Hypertension using a digital sphygmomanometer Omron HEM-711DLX Pulse pressure PP will be calculated from the difference between SBP and DBP values All individuals will undergo ambulatory BP monitoring ABPM for a period of 24 hours using the Spacelabs 90217 equipment Spacelabs Inc Redmon WA USA Patients will be instructed to maintain and record normal daily activities The averages of SBP DBP and PP will be evaluated
Assessment of Biochemical and Inflammatory Parameters - Fasting blood samples will be collected and the following tests will be carried out glucose glycated hemoglobin A1C total cholesterol and fractions urea creatinine renin aldosterone cortisol creatinine clearance and microalbuminuria The biomarkers norepinephrine dopamine adrenaline adrenocorticotropic hormones ACTH and cortisol acetylcholinesterase ultrasensitive C-reactive protein interleukins 2 8 10 and 12 IL-2 IL-8 IL-10 and IL-12 will be determined by ELISA according to the manufacturers instructions
ABPM - It will be performed with the CardioMAPA Monitor - Cardios - Brazil with standardized measurements every 15 minutes during the waking period and every 20 minutes during the sleeping period The data will be considered valid when monitoring takes place for a minimum period of 21 hours with a minimum number of forty measurements during wakefulness and ten measurements during sleep
Determination of Central Blood Pressure and Amplification Index AIx - The SphygmoCor CPV system AtCor Medical USA is a sophisticated non-invasive diagnostic tool for clinical assessment of central blood pressure This system derives central aortic pulse wave pressure systolic diastolic and pulse using pulse wave pressure recorded by the radial artery Pulse wave analysis predicts parameters including PAC and indications of vascular stiffness Measurements are made using a pressure transducer tonometer positioned in the required artery and then the pulse wave is recorded Furthermore this equipment provides information on arterial stiffness by analyzing the Augmentation Index Amplification Index AIx defined by the ratio between the pressure determined by the reflected wave and the ejection wave capable of providing information on arterial stiffness
Assessment of Clinical Parameters - BP measurements will be taken according to the recommendations recommended by the VIII Brazilian Guidelines on Arterial Hypertension using a digital sphygmomanometer Omron HEM-711DLX Pulse pressure PP will be calculated from the difference between SBP and DBP values All individuals will undergo ambulatory BP monitoring ABPM for a period of 24 hours using the Spacelabs 90217 equipment Spacelabs Inc Redmon WA USA Patients will be instructed to maintain and record normal daily activities The averages of SBP DBP and PP will be evaluated
Assessment of Biochemical and Inflammatory Parameters - Fasting blood samples will be collected and the following tests will be carried out glucose glycated hemoglobin A1C total cholesterol and fractions urea creatinine renin aldosterone cortisol creatinine clearance and microalbuminuria The biomarkers norepinephrine dopamine adrenaline adrenocorticotropic hormones ACTH and cortisol acetylcholinesterase ultrasensitive C-reactive protein interleukins 2 8 10 and 12 IL-2 IL-8 IL-10 and IL-12 will be determined by ELISA according to the manufacturers instructions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None