BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Hemo Sapiens, Inc.
- Enrollment
- 183
- Locations
- 5
- Primary Endpoint
- Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 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.
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 of education efforts and antihypertensive drugs, blood pressure control rates remain low. The most common cause of uncontrolled BP is inadequate pharmacological treatment, because the selection of antihypertensive agents is often done independently of the hemodynamic status of the patient (volemia, peripheral resistance, cardiac inotropy, heart rate). Several studies confirmed the value of using impedance cardiography (ICG)-derived hemodynamic data as an adjunct to therapeutic decision-making in the treatment of hypertension. Working hypothesis: when it is possible to assess the hemodynamic status, and select accordingly the most appropriate pharmacological class of antihypertensive treatment, BP reduction occurs to a greater extent and more rapidly. In the present study an integrated therapeutic approach (IHM-Integrated Hemodynamic Management)was applied, aiming at detecting permanent vasoconstriction and/or hypervolemia and/or hyperinotropy through the HOTMAN System, in order to select the most appropriate antihypertensive drugs.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.
Time Frame: baseline and after 6 months of treatment
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.
Secondary Outcomes
- The percentage of normalization of SBP (<135 mmHg) at ABPM(baseline and after 6 months of treatment)
- The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM(baseline and after 6 months of treatment)
- Rate of side effects(from baseline to 6 months of treatment)
- The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP(baseline and after 6 months of treatment)