Therapeutic effects of a cardiac hormone, named BNP, in patients with poorly controlled high levels of blood pressure
Phase 1
- Conditions
- ncontrolled hypertension (UHT, i.e. blood pressure = 150/90, or = 150/85 mm Hg in diabetic patients) despite treatment with at least twodifferent classes of antihypertensive medications.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-000577-13-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Ambulatory with UHT (ie. SBP/DBP = 150/90 mm Hg, or SBP/DBP = 150/85 mm Hg for diabetic patients ) despite treatment with = 2 antihypertensive
drugs belonging to different classes. 24-hour ambulatory blood pressure measurement (ABPM) at screening confirming UHT (average day-time SBP > 135 and/or DBP >85 mmHg) to exclude white coat syndrome.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Secondary hypertension, estimated glomerular filtration rate (eGFR) < 30 mL/min, heart failure (Ejection Fraction < 40%).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate safety and to determine most effective dose of subcutaneous nesiritide in patients with UHT.;Secondary Objective: To improve renal function, reduce dosage and/or number of required conventional antihypertensive medications, and suppress aldosterone release.;Primary end point(s): The main purpose of this study is to determine a safe and tolerable dose yielding an acceptable acute BP response during 6 hours compared to placebo. An acceptable acute BP response is defined as a reduction of SBP = 10 mm Hg and/or reduction of DBP = 5 mm Hg.;Timepoint(s) of evaluation of this end point: The main statistical analysis is planned when all the participants have completed the treatment phase.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Suppression of aldosterone. Improvement of renal function (by eGFR). Effects on 24-h water and electrolyte excretion. Effects on the endogenous natriuretic peptides system. Change in heart rate variability. Reduced number or dosage of standard anti-hypertensive medications during BNP administration compared to baseline and placebo.;Timepoint(s) of evaluation of this end point: The main statistical analysis is planned when all the participants have completed the treatment phase.