Therapeutic effects of a cardiac hormone, named BNP, in patients with poorly controlled high levels of blood pressure

Therapeutic effects of BNP in uncontrolled hypertensive patients 1 - TENSE 1

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000577-13-NO

Enrollment

Registered

2015-04-15

Start date

2015-09-09

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled hypertension (UHT, i.e. blood pressure = 150/90, or = 150/85 mm Hg in diabetic patients) despite treatment with at least two different classes of antihypertensive medications.

Interventions

Trade Name: Natrecor Pharmaceutical Form: Lyophilisate for suspension for injection INN or Proposed INN: NESIRITIDE CAS Number: 124584-08-3 Concentration unit: mg milligram(s) Concentration type: not

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Secondary hypertension, estimated glomerular filtration rate (eGFR) < 30 mL/min, heart failure (Ejection Fraction < 40%).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Norway

Contacts

Public ContactHassan Z. Khiabani

Clinical Trial Unit, Oslo University Hospital - Rikshospitalet

haskhi@ous-hf.no+4723070898

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026