Using Nesiritide to treat hypertension
Therapeutic Effects of BNP in Hypertensive Patients
This study is testing if Nesiritide can help people with high blood pressure feel better and improve their heart health while they are already taking other blood pressure medications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 3 sites (Oslo and 2 other locations) |
| Trial ID | NCT02608996 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with office systolic blood pressure of 120 mmHg or higher who are currently taking at least one anti-hypertensive medication.
Not a fit: Patients with congestive heart failure, significant heart conditions, or recent myocardial events will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing hypertension and its associated cardiovascular risks.
How similar studies have performed: Previous studies have shown promise in using natriuretic peptides for cardiovascular conditions, suggesting potential success for this approach.
Eligibility criteria
Show full 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.
Where this trial is running
Oslo and 2 other locations
- Oslo University Hopital, Rikshospitalet — Oslo, Norway (Not_yet_recruiting)
- Oslo University Hospital, Ullevål Hospital — Oslo, Norway (Recruiting)
- Akershus University Hospital — Strømmen, Norway (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.