Study MIPAE - Melatonin and Essential Arterial Hypertension
NCT ID: NCT05257291
Last Updated: 2023-02-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-02
Study Completion Date
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study MIPAE - Melatonin and essential arterial hypertension.
Study with dietary supplement, prospective and monocentric (randomized control trial). 1 mg/day of melatonin has been administered for one year to a group of patients suffering from essential hypertension (from at least one year) and who are already on antihypertensive therapy. This group has been compared with as many hypertensive patients on antihypertensive therapy to whom melatonin has not been administered. Each of the participants have been evaluated at the beginning of the study and after one year considering:
* systolic and diastolic blood pressure;
* echocardiographic values (Vivid Q, GE Healthcare);
* applanation tonometry (SphygmoCor, AtCor Medical);
* peripheral arterial tonometry (EndoPAT-2000, Itamar);
* melatonin levels and total circulating antioxidant capacity after peripheral venous blood sampling.
The aim of the study was to evaluate the antioxidant and vasoprotective effects of melatonin, evaluating both plasma changes and directly studying the possibility of a real remodeling and improvement of cardiac structures.
Study with dietary supplement, prospective and monocentric (randomized control trial). 1 mg/day of melatonin has been administered for one year to a group of patients suffering from essential hypertension (from at least one year) and who are already on antihypertensive therapy. This group has been compared with as many hypertensive patients on antihypertensive therapy to whom melatonin has not been administered. Each of the participants have been evaluated at the beginning of the study and after one year considering:
* systolic and diastolic blood pressure;
* echocardiographic values (Vivid Q, GE Healthcare);
* applanation tonometry (SphygmoCor, AtCor Medical);
* peripheral arterial tonometry (EndoPAT-2000, Itamar);
* melatonin levels and total circulating antioxidant capacity after peripheral venous blood sampling.
The aim of the study was to evaluate the antioxidant and vasoprotective effects of melatonin, evaluating both plasma changes and directly studying the possibility of a real remodeling and improvement of cardiac structures.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cortisol Secretion, Sensitivity and Activity and Hypertension
NCT05766085
Hypercortisolism
Arterial Hypertension
UNKNOWN
Renin-Angiotensin System Inhibitors and COVID-19
NCT04331574
COVID-19
Hypertension
Cardiovascular Diseases
UNKNOWN
Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism
NCT04991961
Hypertension
Primary Aldosteronism
COMPLETED
Prospective Study on Primary Aldosteronism in Resistant Hypertension
NCT04213963
Resistant Hypertension
Primary Aldosteronism
Refractory Hypertension
+3 more
RECRUITING
Efficacy of a Natural Ingredient on Blood Pressure
NCT03471533
Hypertension
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypertension is a pathological condition characterized by a constant and not occasional increase in systolic and diastolic blood pressure values. This pathology represents one of the most important public health problems in industrialized countries, as it affects more than 25-30% of the adult population and can cause serious and even fatal complications. It is in fact considered the major risk factor of mortality and pathological effect at cardiovascular, encephalic and renal level.
The classification of hypertension suggested by the ESC/ESH Guidelines defines diastolic blood pressure (PAD) values of 80-84 mmHg and systolic blood pressure (PAS) values of 120-129 mmHg as "normal" in a healthy adult. Blood pressure values between 90-99 mmHg (PAD) and 140-159 mmHg (PAS) define grade 1 hypertension.Between 100-109 mmHg (PAD) and 160-179 mmHg (PAS) define grade 2 hypertension. For values above 110 mmHg (PAD) and 180 mmHg (PAS), determine grade 3 hypertension (after 60 years of age slightly higher values are accepted). Although many antihypertensive drug therapies exist today, patients often show a lack of response to pharmacological treatment due to numerous factors of both genetic and environmental nature that contribute to determine the clinical picture and the poor response to the set therapeutic regime. Recent studies aimed at clarifying the pathophysiology of resistant hypertension are highlighting new pathophysiological mechanisms potentially involved in the genesis of this clinical condition. Since essential hypertension and vascular and cardiac dysfunctions seem to be closely related, the identification of molecules/substances that can at least help to reduce the alterations induced by the pathogenetic process of essential hypertension is a priority. In recent years, melatonin has shown important and interesting antihypertensive therapeutic potential. It has also been demonstrated by some authors of this project, in an animal model of arterial hypertension, that melatonin, thanks to its antioxidant properties, is able to regress structural alterations of both the aorta and small mesenteric resistance arteries in an animal model of arterial hypertension.
It is therefore necessary to investigate, also in humans, the correlation among essential arterial hypertension, levels of circulating melatonin and onset of cardiovascular events.
Furthermore, it is of fundamental importance to remember that, to date, following treatment with melatonin, even at high doses, show only rare and minimal adverse effects, including daytime drowsiness, dizziness and headaches.
The aim of the study was, therefore, to evaluate the antihypertensive, antioxidant and vasoprotective effects of melatonin in adult patients suffering from at least 1 year essential hypertension and in antihypertensive therapy. In a broad sense, the aim will be to contribute to current knowledge in terms of effective treatment and reduced impact of cardiovascular changes related to hypertension.
To do this, a total of 23 adult patients (mean age 54 years old) suffering from essential arterial hypertension and undergoing concurrent antihypertensive therapy were enrolled by the Cardiology Unit of the Spedali Civili di Brescia (Italy). The participants were randomly divided into a group to which melatonin was administered orally (1 mg/day for one year - "melatonin" group). This group of patients was then compared with a group of hypertensive patients on antihypertensive therapy who did not take melatonin ("control" group). In particular, patients with essential hypertension for at least 1 year were selected and enrolled.
With regard to the number of samples, reference has been made to recent studies conducted at our Institute. The sample size (alpha 0.05, power 80%) needed to catch a 2 tissue strain modification of the ascending aorta is 6.2% of the longitudinal 2D strain of the left ventricle 21, 0.1 of VAC is 10, 0.25 of RH-PAT index 17, 0.5 m/s in cfPWV is 12. In addition, patients after enrolment have been randomized 1:1 in the two groups; randomization by random number generation minimizes selection prejudices/errors in subdivising into groups and allows to better evaluate the possible effects of melatonin treatment on hypertensive patients (on antihypertensive therapy) compared to hypertensive patients (on antihypertensive) therapy who have not taken melatonin, while the other variables and the analysis to be performed have been kept constant.
All patients with essential hypertension (in antihypertensive therapy) enrolled in the study received the informed consent document and the information document together with clear and understandable explanations/information about the study. In addition, the investigating physician is available to enlisted patients for all necessary information and also for any subsequent questions/curiosities, as well as for the reporting of any adverse effects that he or she undertakes to notify promptly.
In addition, the supply of melatonin tablets required for 30 ± 3 days of treatment (35 tablets of 1 mg melatonin) have been delivered by the investigating physician only to patients enrolled in the "melatonin" group at the time of enrolment and for the following 11 months of the trial.
At the time of enrolment, the investigator has also provided all enlisted subjects a diary on which to record the time of melatonin intake (only for the "melatonin" group), the number of hours of sleep at night, the systolic and diastolic blood pressure values measured weekly by the patient himself and the onset of any adverse effects. At the end of the study, the investigator collected the diaries of all patients enrolled in the study in order to analyze and archive the data together with the evaluation of the previous medical history.
At the beginning of the study and after one year, the patients were evaluated during a medical examination considering:
* blood pressure (weekly evaluation carried out by the patient and monthly check-up carried out by the investigating doctor during meetings with the patient);
* heart rate;
* endothelial parameters: RHI, LnRHI, peripheral AIx@75;
* arterial stiffness parameters: central blood pressure, AIx@75 radial, cfPWV, SEVR;
* echocardiographic parameters: dimensions of atria and ventricles, stenosis and valve insufficiencies, systolic function VS (FE) and VD (TAPSE, FAC, S' TSI), diastolic function VS and VD (E/A, DT, E/E', E'/A'), dimensions and elastic properties of the ascending aorta (compliance, distensibility, stiffness index, elastic modulus of Peterson, PWV, M-mode strain, tissue strain), elongated aortic (Ea) and ventricular telediastolic sinintra (Ees), ventricular-arterial coupling (VAC=Ea/Ees), 2D longitudinal/radial/circonferential strain of VS, longitudinal strain of VD and left atrium (LAA and LAS), torsion of VS;
* laboratory parameters: blood melatonin levels and total circulating antioxidant capacity.
The classification of hypertension suggested by the ESC/ESH Guidelines defines diastolic blood pressure (PAD) values of 80-84 mmHg and systolic blood pressure (PAS) values of 120-129 mmHg as "normal" in a healthy adult. Blood pressure values between 90-99 mmHg (PAD) and 140-159 mmHg (PAS) define grade 1 hypertension.Between 100-109 mmHg (PAD) and 160-179 mmHg (PAS) define grade 2 hypertension. For values above 110 mmHg (PAD) and 180 mmHg (PAS), determine grade 3 hypertension (after 60 years of age slightly higher values are accepted). Although many antihypertensive drug therapies exist today, patients often show a lack of response to pharmacological treatment due to numerous factors of both genetic and environmental nature that contribute to determine the clinical picture and the poor response to the set therapeutic regime. Recent studies aimed at clarifying the pathophysiology of resistant hypertension are highlighting new pathophysiological mechanisms potentially involved in the genesis of this clinical condition. Since essential hypertension and vascular and cardiac dysfunctions seem to be closely related, the identification of molecules/substances that can at least help to reduce the alterations induced by the pathogenetic process of essential hypertension is a priority. In recent years, melatonin has shown important and interesting antihypertensive therapeutic potential. It has also been demonstrated by some authors of this project, in an animal model of arterial hypertension, that melatonin, thanks to its antioxidant properties, is able to regress structural alterations of both the aorta and small mesenteric resistance arteries in an animal model of arterial hypertension.
It is therefore necessary to investigate, also in humans, the correlation among essential arterial hypertension, levels of circulating melatonin and onset of cardiovascular events.
Furthermore, it is of fundamental importance to remember that, to date, following treatment with melatonin, even at high doses, show only rare and minimal adverse effects, including daytime drowsiness, dizziness and headaches.
The aim of the study was, therefore, to evaluate the antihypertensive, antioxidant and vasoprotective effects of melatonin in adult patients suffering from at least 1 year essential hypertension and in antihypertensive therapy. In a broad sense, the aim will be to contribute to current knowledge in terms of effective treatment and reduced impact of cardiovascular changes related to hypertension.
To do this, a total of 23 adult patients (mean age 54 years old) suffering from essential arterial hypertension and undergoing concurrent antihypertensive therapy were enrolled by the Cardiology Unit of the Spedali Civili di Brescia (Italy). The participants were randomly divided into a group to which melatonin was administered orally (1 mg/day for one year - "melatonin" group). This group of patients was then compared with a group of hypertensive patients on antihypertensive therapy who did not take melatonin ("control" group). In particular, patients with essential hypertension for at least 1 year were selected and enrolled.
With regard to the number of samples, reference has been made to recent studies conducted at our Institute. The sample size (alpha 0.05, power 80%) needed to catch a 2 tissue strain modification of the ascending aorta is 6.2% of the longitudinal 2D strain of the left ventricle 21, 0.1 of VAC is 10, 0.25 of RH-PAT index 17, 0.5 m/s in cfPWV is 12. In addition, patients after enrolment have been randomized 1:1 in the two groups; randomization by random number generation minimizes selection prejudices/errors in subdivising into groups and allows to better evaluate the possible effects of melatonin treatment on hypertensive patients (on antihypertensive therapy) compared to hypertensive patients (on antihypertensive) therapy who have not taken melatonin, while the other variables and the analysis to be performed have been kept constant.
All patients with essential hypertension (in antihypertensive therapy) enrolled in the study received the informed consent document and the information document together with clear and understandable explanations/information about the study. In addition, the investigating physician is available to enlisted patients for all necessary information and also for any subsequent questions/curiosities, as well as for the reporting of any adverse effects that he or she undertakes to notify promptly.
In addition, the supply of melatonin tablets required for 30 ± 3 days of treatment (35 tablets of 1 mg melatonin) have been delivered by the investigating physician only to patients enrolled in the "melatonin" group at the time of enrolment and for the following 11 months of the trial.
At the time of enrolment, the investigator has also provided all enlisted subjects a diary on which to record the time of melatonin intake (only for the "melatonin" group), the number of hours of sleep at night, the systolic and diastolic blood pressure values measured weekly by the patient himself and the onset of any adverse effects. At the end of the study, the investigator collected the diaries of all patients enrolled in the study in order to analyze and archive the data together with the evaluation of the previous medical history.
At the beginning of the study and after one year, the patients were evaluated during a medical examination considering:
* blood pressure (weekly evaluation carried out by the patient and monthly check-up carried out by the investigating doctor during meetings with the patient);
* heart rate;
* endothelial parameters: RHI, LnRHI, peripheral AIx@75;
* arterial stiffness parameters: central blood pressure, AIx@75 radial, cfPWV, SEVR;
* echocardiographic parameters: dimensions of atria and ventricles, stenosis and valve insufficiencies, systolic function VS (FE) and VD (TAPSE, FAC, S' TSI), diastolic function VS and VD (E/A, DT, E/E', E'/A'), dimensions and elastic properties of the ascending aorta (compliance, distensibility, stiffness index, elastic modulus of Peterson, PWV, M-mode strain, tissue strain), elongated aortic (Ea) and ventricular telediastolic sinintra (Ees), ventricular-arterial coupling (VAC=Ea/Ees), 2D longitudinal/radial/circonferential strain of VS, longitudinal strain of VD and left atrium (LAA and LAS), torsion of VS;
* laboratory parameters: blood melatonin levels and total circulating antioxidant capacity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Essential Hypertension
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
Group of essential hypertensive patients who have received no additional therapies in addition to their established treatment plan (each patient was on specific antihypertensive therapy that has not been changed).
Group Type
NO_INTERVENTION
No interventions assigned to this group
Melatonin treated group
Group of essential hypertensive patients who have received additional therapies consisting in 1 mg/day of melatonin for 1 year, in addition to their established treatment plan.
Group Type
ACTIVE_COMPARATOR
Melatonin
Intervention Type
DRUG
Supplementation with 1 mg/day of melatonin for 1 year
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Melatonin
Supplementation with 1 mg/day of melatonin for 1 year
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Caucasian race;
* Age 40-50;
* Signed written informed consent
* Normal weight;
* Blood pressure: PAD \>90 mmHg and PAS \>140 mmHg;
* Blood pressure in the above mentioned range from at least 1 years
* Fasting blood sugar \< 100 mg/dL;
* Total cholesterol \< 200 mg/dL and triglycerides \< 150 mg/dL;
* Intake of antihypertensive therapies (except nitrates, statins and β-blockers);
* Non-smoking;
* No night shift workers (at least in the last 3 months before recruitment);
* With a regular sleep/wake rhythm;
* No pregnant/nursing women.
* Age 40-50;
* Signed written informed consent
* Normal weight;
* Blood pressure: PAD \>90 mmHg and PAS \>140 mmHg;
* Blood pressure in the above mentioned range from at least 1 years
* Fasting blood sugar \< 100 mg/dL;
* Total cholesterol \< 200 mg/dL and triglycerides \< 150 mg/dL;
* Intake of antihypertensive therapies (except nitrates, statins and β-blockers);
* Non-smoking;
* No night shift workers (at least in the last 3 months before recruitment);
* With a regular sleep/wake rhythm;
* No pregnant/nursing women.
Exclusion Criteria
* Blood pressure: PAD \<90 mmHg and PAS \<140 mmHg
* Heart disease of any kind;
* Autoimmune or rheumatological or vascular diseases other than essential hypertension;
* Anti-hypertensive therapies with nitrates, statins or β-blockers;
* Pregnancy/nursing;
* \< 40 or \> 50 years;
* Worker with night shifts (for a period of less than 3 months before recruitment);
* Continuous irregular sleep/wake rhythm.
* Heart disease of any kind;
* Autoimmune or rheumatological or vascular diseases other than essential hypertension;
* Anti-hypertensive therapies with nitrates, statins or β-blockers;
* Pregnancy/nursing;
* \< 40 or \> 50 years;
* Worker with night shifts (for a period of less than 3 months before recruitment);
* Continuous irregular sleep/wake rhythm.
Minimum Eligible Age
40 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rita Rezzani
PhD, Full Professor of Human Anatomy
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anatomy and Physiopathology Division, Department of Experimental and Clinical Sciences, University of Brescia (Italy), Viale Europa 11, 25123 Brescia, Italy
Brescia, , Italy
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Italy
References
Explore related publications, articles, or registry entries linked to this study.
Acuna-Castroviejo D, Escames G, Venegas C, Diaz-Casado ME, Lima-Cabello E, Lopez LC, Rosales-Corral S, Tan DX, Reiter RJ. Extrapineal melatonin: sources, regulation, and potential functions. Cell Mol Life Sci. 2014 Aug;71(16):2997-3025. doi: 10.1007/s00018-014-1579-2. Epub 2014 Feb 20.
Reference Type
BACKGROUND
Agabiti-Rosei C, De Ciuceis C, Rossini C, Porteri E, Rodella LF, Withers SB, Heagerty AM, Favero G, Agabiti-Rosei E, Rizzoni D, Rezzani R. Anticontractile activity of perivascular fat in obese mice and the effect of long-term treatment with melatonin. J Hypertens. 2014 Jun;32(6):1264-74. doi: 10.1097/HJH.0000000000000178.
Reference Type
BACKGROUND
Andersen LP, Gogenur I, Rosenberg J, Reiter RJ. The Safety of Melatonin in Humans. Clin Drug Investig. 2016 Mar;36(3):169-75. doi: 10.1007/s40261-015-0368-5.
Reference Type
BACKGROUND
Arangino S, Cagnacci A, Angiolucci M, Vacca AM, Longu G, Volpe A, Melis GB. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. Am J Cardiol. 1999 May 1;83(9):1417-9. doi: 10.1016/s0002-9149(99)00112-5.
Reference Type
BACKGROUND
Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. doi: 10.1161/01.atv.0000051384.43104.fc.
Reference Type
BACKGROUND
Cagnacci A, Arangino S, Angiolucci M, Maschio E, Longu G, Melis GB. Potentially beneficial cardiovascular effects of melatonin administration in women. J Pineal Res. 1997 Jan;22(1):16-9. doi: 10.1111/j.1600-079x.1997.tb00297.x.
Reference Type
BACKGROUND
Cagnacci A, Arangino S, Angiolucci M, Melis GB, Facchinetti F, Malmusi S, Volpe A. Effect of exogenous melatonin on vascular reactivity and nitric oxide in postmenopausal women: role of hormone replacement therapy. Clin Endocrinol (Oxf). 2001 Feb;54(2):261-6. doi: 10.1046/j.1365-2265.2001.01204.x.
Reference Type
BACKGROUND
Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
Reference Type
BACKGROUND
Conti A, Conconi S, Hertens E, Skwarlo-Sonta K, Markowska M, Maestroni JM. Evidence for melatonin synthesis in mouse and human bone marrow cells. J Pineal Res. 2000 May;28(4):193-202. doi: 10.1034/j.1600-079x.2000.280401.x.
Reference Type
BACKGROUND
Favero G, Rodella LF, Reiter RJ, Rezzani R. Melatonin and its atheroprotective effects: a review. Mol Cell Endocrinol. 2014 Feb 15;382(2):926-37. doi: 10.1016/j.mce.2013.11.016. Epub 2013 Nov 28.
Reference Type
BACKGROUND
Goor DA, Sheffy J, Schnall RP, Arditti A, Caspi A, Bragdon EE, Sheps DS. Peripheral arterial tonometry: a diagnostic method for detection of myocardial ischemia induced during mental stress tests: a pilot study. Clin Cardiol. 2004 Mar;27(3):137-41. doi: 10.1002/clc.4960270307.
Reference Type
BACKGROUND
Hardeland R, Cardinali DP, Srinivasan V, Spence DW, Brown GM, Pandi-Perumal SR. Melatonin--a pleiotropic, orchestrating regulator molecule. Prog Neurobiol. 2011 Mar;93(3):350-84. doi: 10.1016/j.pneurobio.2010.12.004. Epub 2010 Dec 28.
Reference Type
BACKGROUND
Intengan HD, Schiffrin EL. Vascular remodeling in hypertension: roles of apoptosis, inflammation, and fibrosis. Hypertension. 2001 Sep;38(3 Pt 2):581-7. doi: 10.1161/hy09t1.096249.
Reference Type
BACKGROUND
Kawasaki T, Sasayama S, Yagi S, Asakawa T, Hirai T. Non-invasive assessment of the age related changes in stiffness of major branches of the human arteries. Cardiovasc Res. 1987 Sep;21(9):678-87. doi: 10.1093/cvr/21.9.678.
Reference Type
BACKGROUND
Laurent S, Boutouyrie P. The structural factor of hypertension: large and small artery alterations. Circ Res. 2015 Mar 13;116(6):1007-21. doi: 10.1161/CIRCRESAHA.116.303596.
Reference Type
BACKGROUND
Lundberg MS, Crow MT. Age-related changes in the signaling and function of vascular smooth muscle cells. Exp Gerontol. 1999 Jul;34(4):549-57. doi: 10.1016/s0531-5565(99)00036-4.
Reference Type
BACKGROUND
Meissner A, Minnerup J, Soria G, Planas AM. Structural and functional brain alterations in a murine model of Angiotensin II-induced hypertension. J Neurochem. 2017 Feb;140(3):509-521. doi: 10.1111/jnc.13905. Epub 2016 Dec 21.
Reference Type
BACKGROUND
Nawaz W, Khan FU, Khan MZ, Gang W, Yang M, Liao X, Zhang L, Ihsan AU, Khan A, Han L, Zhou X. Exo-organoplasty interventions: A brief review of past, present and future directions for advance heart failure management. Biomed Pharmacother. 2017 Apr;88:162-172. doi: 10.1016/j.biopha.2017.01.048. Epub 2017 Jan 16.
Reference Type
BACKGROUND
Oktay AA, Lavie CJ, Milani RV, Ventura HO, Gilliland YE, Shah S, Cash ME. Current Perspectives on Left Ventricular Geometry in Systemic Hypertension. Prog Cardiovasc Dis. 2016 Nov-Dec;59(3):235-246. doi: 10.1016/j.pcad.2016.09.001. Epub 2016 Sep 8.
Reference Type
BACKGROUND
Orabona R, Sciatti E, Vizzardi E, Bonadei I, Valcamonico A, Metra M, Frusca T. Endothelial dysfunction and vascular stiffness in women with previous pregnancy complicated by early or late pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):116-123. doi: 10.1002/uog.15893.
Reference Type
BACKGROUND
Rezzani R, Porteri E, De Ciuceis C, Bonomini F, Rodella LF, Paiardi S, Boari GE, Platto C, Pilu A, Avanzi D, Rizzoni D, Agabiti Rosei E. Effects of melatonin and Pycnogenol on small artery structure and function in spontaneously hypertensive rats. Hypertension. 2010 Jun;55(6):1373-80. doi: 10.1161/HYPERTENSIONAHA.109.148254. Epub 2010 Apr 26.
Reference Type
BACKGROUND
Rizzoni D, Porteri E, De Ciuceis C, Boari GE, Zani F, Miclini M, Paiardi S, Tiberio GA, Giulini SM, Muiesan ML, Castellano M, Rosei EA. Lack of prognostic role of endothelial dysfunction in subcutaneous small resistance arteries of hypertensive patients. J Hypertens. 2006 May;24(5):867-73. doi: 10.1097/01.hjh.0000222756.76982.53.
Reference Type
BACKGROUND
Sarkar T, Singh NP. Epidemiology and Genetics of Hypertension. J Assoc Physicians India. 2015 Sep;63(9):61-98.
Reference Type
BACKGROUND
Scuteri A, Nilsson PM, Tzourio C, Redon J, Laurent S. Microvascular brain damage with aging and hypertension: pathophysiological consideration and clinical implications. J Hypertens. 2011 Aug;29(8):1469-77. doi: 10.1097/HJH.0b013e328347cc17.
Reference Type
BACKGROUND
Sorriento D, Santulli G, Del Giudice C, Anastasio A, Trimarco B, Iaccarino G. Endothelial cells are able to synthesize and release catecholamines both in vitro and in vivo. Hypertension. 2012 Jul;60(1):129-36. doi: 10.1161/HYPERTENSIONAHA.111.189605. Epub 2012 Jun 4.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NP 2717
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans
NCT03828955
COMPLETED
NA
Pharmacogenomic Evaluation of Antihypertensive Responses 2
NCT01203852
COMPLETED
PHASE4
Effect of Chronotherapy on Blood Pressure - Time of Intake of Blood Pressure Lowering Drugs
NCT05322967
RECRUITING
NA
HIGH Altitude CArdiovascular REsearch in the ANDES
NCT01830530
COMPLETED
PHASE4
Hypertension in High School Students
NCT06049641
COMPLETED
Genetic Architecture of Natriuretic Peptides and Blood Pressure Response
NCT07118592
NOT_YET_RECRUITING
NA
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs
NCT03560804
COMPLETED
NA
Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives
NCT04531124
NOT_YET_RECRUITING
Effect of Antihypertensive Agents Over Sleep Apnea
NCT01896661
COMPLETED
PHASE3
Resistant Arterial Hypertension Cohort Study
NCT01083017
COMPLETED
Prevention of Diabetes and Hypertension
NCT00456963
TERMINATED
PHASE4
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers
NCT01091753
COMPLETED
PHASE4
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
NCT03558022
COMPLETED
NA
The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients
NCT05165823
COMPLETED
NA
The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)
NCT02572024
COMPLETED
NA
Accomplices of Insulin Resistance in Prehypertension: Aldosterone?
NCT01112007
COMPLETED
The Contractile Response of the Thoracic Aorta to Vasoactive Substances
NCT06374836
COMPLETED
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
NCT00353652
COMPLETED
PHASE4
Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients
NCT00135551
COMPLETED
PHASE4
Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure
NCT03424993
COMPLETED
PHASE4
Prehypertension and Dietary Supplements - The PYRAMIDS Study
NCT01682291
UNKNOWN
PHASE4
Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System
NCT06320171
COMPLETED
NA
Sodium-Potassium Blood Pressure Trial in Children
NCT00000521
COMPLETED
PHASE4
Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients
NCT00409487
COMPLETED
PHASE4