Status:
COMPLETED
BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
Lead Sponsor:
Hemo Sapiens, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 th...
Detailed Description
Early BP control in hypertensives guarantees the best prevention of cardiovascular events on the long term (2007 ESH-ESC Guidelines on the Management of Hypertension; VALUE study). However, in spite o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01482364
Start Date
October 1 2011
End Date
January 1 2014
Last Update
March 24 2015
Active Locations (5)
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1
Tallinn Hypertension Excellence Centre
Tallinn, Estonia
2
Hôpital européen Georges Pompidou
Paris, France
3
Milano Hypertension Excellence Center
Milan, Italy
4
University of Oslo, Ullevaal Hospital
Oslo, Norway