Nesiritide in Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02608996
• Date of registration: 09/11/2015
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Nesiritide in Hypertension TENSE1
• Scientific title: Therapeutic Effects of BNP in Hypertensive Patients
• Date of first enrolment: December 2015
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02608996
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Alessandro Cataliotti, MD, PhD

• Name: Alessandro Cataliotti, MD, PhD
• Affiliation: Oslo University Hospital and University of Oslo

Key inclusion & exclusion criteria

Inclusion Criteria:

- Office systolic blood pressure (SBP) = 120 mmHg and treatment with at least one
anti-hypertensive medication. Unchanged medication regimen the last two weeks prior to
inclusion.

- Average day-time SBP > 115 on a 24-h ambulatory BP measurement at screening.

Exclusion Criteria:

- Congestive Heart Failure (any New York Heart Association class)

- Ejection Fraction = 40 %

- Known, not appropriately treated, secondary hypertension

- Myocardial infarction within 3 months of screening

- Unstable angina within 14 days of screening, or any evidence of myocardial ischemia

- Pulmonary hypertension

- Aortic stenosis with maximum jet velocity > 2,5 m/s

- Other valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy,
constrictive pericarditis or biopsy proven active myocarditis

- Sustained Ventricular Tachycardia or Ventricular Fibrillation within 14 days of
screening

- Sustained Atrial Fibrillation

- Second or third degree atrioventricular block without a permanent cardiac pacemaker

- Cerebrovascular event within 3 months of screening, or other evidence of significantly
compromised cerebral perfusion

- Proteinuria defined as albumin:creatinine ratio > 100 (equivalent to an excretion of >
1 g/day)

- Nephrotic syndrome

- Body Mass Index > 35

- Total bilirubin of > 25 µmol/L, aspartate aminotransferase or alanine aminotransferase
1.5 times the upper limit of normal range

- Renal insufficiency assessed by estimated glomerular filtration rate (GFR) < 30 ml/min

- Serum sodium of = 135 mmol/L and = 150 mmol/L

- Serum potassium of = 3.5 mmol/L and = 5.5 mmol/L

- Women taking hormonal contraceptives containing estrogens

- Pregnancy

- Patients on prolonged, i.e. more than 30 days, immunosuppressant therapy

- Patients with known, active malignancies

- Patients with orthostatic hypotension

- Participation in a trial with an investigational product within the previous three
months

- Any contraindication listed on the Investigator's Brochure of the Investigational
Medicinal Product

- Any reason why, in the opinion of the investigator, the patient should not
participate.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Placebo

Drug: Nesiritide

Primary Outcome(s)

Changes in blood pressure (BP) [Time Frame: 48 hours, from day 1 to day 2. Specifically, it will be assessed before first injection(baseline data) up to 12 hours post last injection.]

Secondary Outcome(s)

Hormonal changes assessed by aldosterone, atrial natriuretic peptide (ANP), N Terminal-ANP, BNP, N Terminal-proBNP, C-type natriuretic peptide and cyclic guanosyl monophosphate. [Time Frame: 48 hours, from day 1 to day 2. Specifically, it will be assessed before first injection (baseline data) up to 12 hours post last injection.]

Number of participants with treatment-related adverse events defined as all untoward and unintended responses to the treatment related to any dose administered. [Time Frame: 48 hours, from day 1 to day 2. Specifically, it will be assessed after first injection, up to 12 hours post last injection. A second determination will be done within 3 weeks after last injection (21 days assessment).]

Renal function as assessed by estimated glomerular filtration rate (eGFR) [Time Frame: 48 hours, from day 1 to day 2. Specifically, it will be assessed before first injection (baseline data) up to 12 hours post last injection.]

Secondary ID(s)

2015-000577-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Akershus

University of Oslo