scholarly journals Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Vítor Magnus Martins ◽  
Lucas Helal ◽  
Filipe Ferrari ◽  
Leonardo Grabinski Bottino ◽  
Sandra Costa Fuchs ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Primary Hypertension ◽  
Blood Pressure Lowering ◽  
Pressure Monitoring ◽  
Pressure Lowering ◽  
The Mean

Abstract Background Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, but the equivalent doses of their more common agents, chlorthalidone and hydrochlorothiazide, are still unclear. Further, concerns exist regarding adverse metabolic effects, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. This trial aims to investigate the efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride at different doses, for initial management of patients with primary hypertension. Methods/design This is a factorial (2 × 2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) in patients with primary hypertension. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters, and proportion of patients who achieved blood pressure control. The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ambulatory blood pressure monitoring, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate for losses, resulting in 84 patients being randomized. Discussion Diuretics are pivotal drugs for the treatment of hypertension. Chlorthalidone and hydrochlorothiazide, in combination with amiloride in multiple doses, will be tested in terms of blood pressure lowering efficacy and safety. Since the intensity of blood pressure reduction is the major determinant of reduction in cardiovascular risk in hypertensive patients, this study will help to determine which combination of diuretics represents the most appropriate treatment for this population. Trial registration ClinicalTrials.gov, NCT03928145. Registered on 25 April 2019. Last update on 29 April 2019.

scholarly journals Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial.

2019 ◽  
Author(s):  
Vitor Magnus Martins ◽  
Lucas Helal ◽  
Filipe Ferrari ◽  
Leonardo Grabinski Bottino ◽  
Sandra Costa Fuchs ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Primary Hypertension ◽  
Blood Pressure Lowering ◽  
Pressure Monitoring ◽  
Pressure Lowering ◽  
The Mean

Abstract Background Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Further, there exist concerns regarding adverse metabolic effects which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. This trial aims to investigate the efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension. Methods This is a factorial (2x2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) in patients with primary hypertension. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters and proportion of patients who achieved blood pressure control. The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, and standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ambulatory blood pressure monitoring, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate losses, resulting in 84 patients being randomized. Discussion Diuretics are pivotal drugs for the treatment of hypertension. Chlorthalidone and hydrochlorothiazide, in combination with amiloride in multiple doses, will be tested in terms of blood pressure lowering efficacy and safety. Since the intensity of blood pressure reduction is the major determinant of reduction in cardiovascular risk in hypertensive patients, this study will help to determine which combination of diuretics represents the most appropriate treatment for this population.

scholarly journals Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial.

2019 ◽  
Author(s):  
Vitor Magnus Martins ◽  
Lucas Helal ◽  
Filipe Ferrari ◽  
Leonardo Grabinski Bottino ◽  
Sandra Costa Fuchs ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Primary Hypertension ◽  
Blood Pressure Lowering ◽  
Pressure Monitoring ◽  
Pressure Lowering ◽  
The Mean

Abstract Background Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. This trial aims to investigate the efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension. Methods This is a factorial (2x2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) in patients with primary hypertension. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters and proportion of patients who achieved blood pressure control. The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, and standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ambulatory blood pressure monitoring, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate losses, resulting in 84 patients being randomized. Discussion Diuretics are pivotal drugs for the treatment of hypertension. Chlorthalidone and hydrochlorothiazide, in combination with amiloride in multiple doses, will be tested in terms of blood pressure lowering efficacy and safety. Since the intensity of blood pressure reduction is the major determinant of reduction in cardiovascular risk in hypertensive patients, this study will help to determine which combination of diuretics represents the most appropriate treatment for this population.

Ambulatory Blood Pressure Monitoring in Multiple Myeloma Patients Treated with VAD Protocol.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5124-5124
Author(s):  
Angelika Pyszel ◽  
Monika Biedron ◽  
Rafal Poreba ◽  
Tomasz Wrobel ◽  
Grzegorz Mazur ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Multiple Myeloma ◽  
Diastolic Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Pressure Monitoring ◽  
Hypertensive Patients ◽  
The Mean ◽  
The Impact

Abstract BACKGROUND: Corticosteroids are still a cornerstone in multiple myeloma (MM) therapy, both as a single agent and as a part of many protocols, including VAD regimen (vincristine, adriblastine, dexamethasone). Corticosteroids are known to be involved in blood pressure (BP) regulation and to affect this parameter. The impact of dexamethasone (Dex) administration on BP in MM patients during VAD protocol treatment is poorly documented. AIM: The purpose of the study was to evaluate the blood pressure changes during Dex administration in patients treated with VAD protocol due to MM. METHODS: Thirteen patients with MM (7 men and 6 women; mean age 62,45 ± 8,14) were assessed. Primary hypertensive patients (7 persons) were not excluded. They were administered Dex in standard dose of 40 mg (day 1–4, 9–12, 17–21) according to VAD protocol. Blood pressure was assessed by the use of commercially available instruments of Ambulatory Blood Pressure Monitoring (ABPM). The BP recordings lasted 48 hours, were started on the day before the first day of VAD and were obtained every 10 minutes during mornings, every 15 minutes during the rest of days and every 20 minutes during nights. Average of systolic and diastolic blood pressure (SBP/DBP) were estimated for the 2-hour time before Dex and for the 14-hour time in the 2-hour periods after Dex. Minimal and maximal range of SBP/DBP increase and the mean amount of SBP/DBP increase were also determined. RESULTS: 48-hour BP recordings revealed a significant increase in systolic and diastolic blood pressure after Dex administration in all patients. SBP and DBP began to increase after 3 hours after Dex, then rose continually and reached the peak in the period from 6 to 10 hour after Dex. In comparison to 2-hour period before Dex, in which SBP/DBP amounted 139,63/82,92 ± 23,47/9,38 mmHg, the mean SBP/DBP increase rate was: in the 2–4 hour period after Dex - 146,68/88,15 ± 24,38/10,51 mmHg (p<0,05), in the 6–8 – 148,07/92,66 ± 14,07/9,04 mmHg (ns), in the 8–10 – 147,8/87,99 ± 14,07/9,04 mmHg (p<0,01), in the 10–12 – 143,44/86,12 ± 17,22/9,77 mmHg (p<0,05) and in the 12–14 – 144,47/88,59 ± 17,04/12,54 mmHg (p<0,01). The minimal range of SBP/DBP increase was 10,50/−2,00 mmHg, maximal range of SBP/DBP increase was 35,43/40,00 mmHg and the mean amount of SBP/DBP increase was 20,06/11,6 ± 8,36/14,23 mmHg. CONCLUSION: Our preliminary study revealed that Dex administration causes an increase in BP in all patients. The mean increase in BP amounted 20,06/11,6 ± 8,36/14,23 mmHg and was similar in all patients, regardless their initial value of BP. So our study demonstrates the need of individualized hypertension treatment with strict control of BP in hypertensive patients when corticosteroid therapy is indicated.

scholarly journals Ambulatory blood pressure monitoring changes in hypertensive patients

2019 ◽  
Vol 2 (8) ◽  
pp. 53-57
Author(s):  
V.S. Pasko
Keyword(s):  
Blood Pressure ◽  
Arterial Pressure ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Pressure Monitoring ◽  
Middle Aged ◽  
Hypertensive Patients

The aim of the study was to determine the peculiarities of ABPM indices in middle-aged and elderly hypertensive patients depending on the daily BP profile. Material and methods. Indices of ambulatory blood pressure monitoring were identified in 57 middle-aged patients (45-59 years) (group I) and 43 elderly patients (60-74 years) (group II), who underwent two-week in-patient treatment. The control group consisted of 15 patients for every of the surveyed categories (group III - middle-aged and group IV – elderly respectively) matched with basic by age and gender. Results. We have shown that one of the factors that determines the change in hemodynamics in patients with essential hypertension is age, with the age patients experience the decrease in diastolic blood pressure with steadily increased systolic blood pressure, that should be considered in the prescription of antihypertensive treatment. With age, a gradual increase in systolic blood pressure is associated with the increased aortic stiffness, partially with the increase in collagen and the decrease in elastic fibrils and the formation of isolated systolic hypertension. Thus, it is proved that in the formation of isolated hypertension the growth of pulse blood pressure for more than 60 mm Hg is unfavorable in a development of cerebrovascular events. Pulse arterial blood pressure was stronger risk factor than systolic blood pressure and diastolic blood pressure or average arterial pressure in the elderly. Recently, taking into account age characteristics, all three indices were recognized as comparable predictors at the age of 50-59 years as the transitional period, and at the age of 60-79 years diastolic blood pressure adversely affecting the cardiovascular risk, increased pulse blood pressure prognostically above the level of systolic arterial pressure.

scholarly journals Diabetic Cardiovascular Autonomic Neuropathy, the Handgrip Test and Ambulatory Blood Pressure Monitoring Parameters: Are There Any Diagnostic Implications?

2020 ◽  
Vol 9 (10) ◽  
pp. 3322
Author(s):  
Miklós Kempler ◽  
Noémi Hajdú ◽  
Zsuzsanna Putz ◽  
Ildikó Istenes ◽  
Orsolya Vági ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Autonomic Neuropathy ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Cardiovascular Autonomic Neuropathy ◽  
Inverse Association ◽  
Pressure Monitoring ◽  
Handgrip Test

Cardiovascular autonomic neuropathy (CAN) is a common complication of diabetes mellitus. Cardiovascular reflex tests (CARTs) are the gold standard in the diagnosis of CAN, but the handgrip test is no longer recommended to be performed. Previously, the inverse association between the presence of hypertension and handgrip test abnormality was demonstrated and hypertension as major cause for excessive diastolic blood pressure rise during handgrip testing in diabetic individuals proposed. The aim of the present study is to describe more precisely the association between handgrip test and hypertension by performing ambulatory blood pressure monitoring (ABPM) among diabetic patients. A more comprehensive evaluation of the relationship between cardiovascular autonomic function, hypertension and the handgrip test was targeted using heart rate variability (HRV) analysis. Our study involved 163 patients with diabetes. Cardiovascular autonomic neuropathy was assessed by the CARTs and sustained handgrip test was performed. All patients underwent ABPM and HRV analysis well. CAN was diagnosed in 69 patients. Significant associations were found between the diastolic blood pressure increase in response to handgrip exercise and the 24-h (rho = 0.245, p = 0.003), daytime (rho = 0.230, p = 0.005) and night-time (rho = 0.230, p = 0.006) mean systolic and 24-h diastolic (rho = 0.176, p = 0.034) blood pressure values, systolic blood pressure load (rho = 0.252, p = 0.003) and systolic (rho = 0.236, p = 0.005) and diastolic (rho = 0.165, p = 0.047) hyperbaric impacts. Higher values of ambulatory blood pressure monitoring parameters are associated with greater increases in diastolic blood pressure during isometric handgrip exercise. Diastolic blood pressure elevations during the handgrip test are also correlated, in order to diminished heart rate variability parameters attributable to parasympathetic dysfunction highlighting the pivotal role of sympathetic overactivity in evolving handgrip test results. Our study provides further evidence on the inverse association between handgrip test abnormality and hypertension in diabetic patients.

Regression to the mean of repeated ambulatory blood pressure monitoring in five studies

2019 ◽  
Vol 37 (1) ◽  
pp. 24-29 ◽  
Author(s):  
Myles N. Moore ◽  
Emily R. Atkins ◽  
Abdul Salam ◽  
Michele L. Callisaya ◽  
James L. Hare ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ambulatory Blood Pressure Monitoring ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Regression To The Mean ◽  
Pressure Monitoring ◽  
The Mean
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