Using Nesiritide to treat hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Nesiritide, a synthetic form of a natural hormone, on patients with hypertension who are already on anti-hypertensive medication. The study aims to understand how Nesiritide can help manage blood pressure and improve heart function by addressing the derangement of the natriuretic peptide system associated with hypertension. Participants will be monitored for changes in their blood pressure and overall cardiovascular health during the intervention period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oslo University Hospital, Ullevål Hospital
  Oslo, Norway Recruiting
• Akershus University Hospital
  Strømmen, Norway Recruiting
• Oslo University Hopital, Rikshospitalet
  Oslo, Norway Not yet recruiting

Study contacts

• Principal investigator: Alessandro Cataliotti, MD, PhD — Oslo University Hospital and University of Oslo
• Study coordinator: Alessandro Cataliotti, MD, PhD
• Email: alessandro.cataliotti@medisin.uio.no
• Phone: +47 23016807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.