Hypertension Clinical Trial
— BEAUTYOfficial title:
BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e. without IHM) during a 6 months intensive treatment program.
Status | Completed |
Enrollment | 183 |
Est. completion date | January 2014 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - patients of either sex presenting with essential hypertension - having sustained hypertension both at office BP (SBP>140 mmHg) and at ABPM (SBP>135 mmHg daytime) - treated with 2 to 4 antihypertensive drugs - aged = 18 and = 75 years - after signature of the Informed Consent Form (ICF) Exclusion Criteria: - pregnant or lactating female - type 1 diabetes - patients with pacemaker (ventricular/dual chamber) - Severe aortic insufficiency - severe hypertension (SBP = 180 mmHg and/or DBP =110 mmHg) - resistant hypertension requiring at least 5 antihypertensive drugs - secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing's syndrome - serious disorders which may limit the ability to evaluate the efficacy or safety of the protocol, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic (criteria for metabolic syndrome), haematological, oncological, neurological, or psychiatric diseases - history of the following pathologies within the last 6 months: - myocardial infarction - unstable angina pectoris - percutaneous coronary intervention - bypass surgery - congestive heart failure stage III-IV - left branch bundle block - atrial fibrillation - hypertensive encephalopathy - stroke - extreme obesity (BMI > 35) - previously enrolled subjects - alcohol or drug abuse in the past 2 years - planned hospitalization during the study period - participation in any other clinical study within 30 days prior to screening visit |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Estonia | Tallinn Hypertension Excellence Centre | Tallin | |
France | Hôpital européen Georges Pompidou | Paris | |
Italy | Milano Hypertension Excellence Center | Milano | |
Norway | University of Oslo, Ullevaal Hospital | Oslo | |
Poland | Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk | Gdansk |
Lead Sponsor | Collaborator |
---|---|
Hemo Sapiens, Inc. |
Estonia, France, Italy, Norway, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up. | Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up. | baseline and after 6 months of treatment | No |
Secondary | The percentage of normalization of SBP (<135 mmHg) at ABPM | The percentage of normalization of SBP (<135 mmHg) at ABPM | baseline and after 6 months of treatment | No |
Secondary | The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM | The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM | baseline and after 6 months of treatment | No |
Secondary | Rate of side effects | Rate of side effects | from baseline to 6 months of treatment | Yes |
Secondary | The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP | The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP | baseline and after 6 months of treatment | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |