HypertensionPhase 1/2TENSE1NCT02608996
Nesiritide in Hypertension
A Phase 1/2 study testing Nesiritide in people with Hypertension, run by Oslo University Hospital at 3 sites in Norway.
Trial summary
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure. Its myocardial complications result from increased mechanical load on the heart. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nesiritide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesNorway
- Study dates
- Dec 2015to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Not yet recruiting
Oslo University Hopital, Rikshospitalet
Oslo, 0424
Hassan Z Khiabani, MD, PhD
Hassan Z Khiabani, MD, PhD
- Recruiting
Oslo University Hospital, Ullevål Hospital
Oslo, 0450
Morten Rostrup, MD, PhD
Kaja K Bergo, MD
- Recruiting
Akershus University Hospital
Strømmen, 1478
My HS Svensson, MD, PhD
My HS Svensson, MD, PhD
About this study
Official title: Therapeutic Effects of BNP in Hypertensive Patients
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure. Its myocardial complications result from increased mechanical load on the heart. Under physiological conditions of increased myocardial load and resulting myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis. However, studies indicate that in subjects with cardiovascular diseases the biological structure of these hormones may be altered, thus reducing their favorable protective activities. New studies indicate that early and moderate hypertension is associated with a derangement of the natriuretic peptide system which is characterized by the lack of activation of biologically active ANP and BNP, while severe hypertension is characterized by cardiac release of altered molecular forms of ANP and BNP that have reduced biological properties and/or enhanced degradation.
The broad objective of this proposal is to advance the biology and therapeutics of the NPs with a special focus on the cardiac peptide BNP in human hypertension. Our proposal is based upon the biological properties of BNP (i.e. natriuretic, renin-angiotensin-aldosterone suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its mechanistic role in human hypertension, and thus its potential as an innovative chronic protein therapeutic to enhance the treatment of patients with hypertension. Importantly, BNP is an endocrine hormone normally produced by the human heart, and it has been approved for the treatment of acute heart failure in USA.
- Conditions
- Hypertension
- Being tested
- Nesiritide, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
Also called Natrecor, BNP
This intervention is designed to determine the optimal dose range of BNP for treatment of patients with uncontrolled hypertension
PlaceboDrug
Also called Saline solution
For comparison to elucidate the true effect of nesiritide
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous BNP | Active comparator | Patients will receive gradually increasing doses (10-25 µg/kg) of subcutaneously administered nesiritide (BNP) twice daily for two days, to determine the feasibility, safety and blood pressure lowering effect of BNP so as to identify the optimal dose. Receives: Drug: Nesiritide |
| Subcutaneous placebo | Placebo comparator | Patients will receive subcutaneously administered placebo twice daily for two days for determination of the effect of BNP. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure (BP)
Office blood pressure and ambulatory blood pressure monitoring (ABPM) recordings will be used for the analysis
Measured: 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 outcomes (3)
Renal function as assessed by estimated glomerular filtration rate (eGFR)
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin C equation will be used to calculate estimated glomerular filtration rate (eGFR).
Measured: 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.
Hormonal changes assessed by aldosterone, atrial natriuretic peptide (ANP), N Terminal-ANP, BNP, N Terminal-proBNP, C-type natriuretic peptide and cyclic guanosyl monophosphate.
Will be measured in plasma, and all but aldosterone in urine Collections.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus
- Responsible party
- Principal investigator, Alessandro Cataliotti, Oslo University Hospital
- Investigators
- Alessandro Cataliotti, MD, PhD, Principal investigator, Oslo University Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608996
- Sponsor's protocol ID
- 2015-000577-13
- Other IDs
- 2015
- Acronym
- TENSE1
- Status last verified
- Dec 2017
- First submitted
- 9 Nov 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of BNP in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02608996
- Acronym / sponsor ID
- TENSE1 / 2015-000577-13
- Conditions
- Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure. Its myocardial complications result from increased mechanical load on the heart. Under physiological conditions of increased myocardial load and resulting myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis. However, studies indicate that in subjects with cardiovascular diseases the biological structure of these hormones may be altered, thus reducing their favorable protective activities. New studies indicate that early and moderate hypertension is associated with a derangement of the natriuretic peptide system which is characterized by the lack of activation of biologically active ANP and BNP, while severe hypertension is characterized by cardiac release of altered molecular forms of ANP and BNP that have reduced biological properties and/or enhanced degradation.
The broad objective of this proposal is to advance the biology and therapeutics of the NPs with a special focus on the cardiac peptide BNP in human hypertension. Our proposal is based upon the biological properties of BNP (i.e. natriuretic, renin-angiotensin-aldosterone suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its mechanistic role in human hypertension, and thus its potential as an innovative chronic protein therapeutic to enhance the treatment of patients with hypertension. Importantly, BNP is an endocrine hormone normally produced by the human heart, and it has been approved for the treatment of acute heart failure in USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous BNP | Active comparator | Drug: NesiritidePatients will receive gradually increasing doses (10-25 µg/kg) of subcutaneously administered nesiritide (BNP) twice daily for two days, to determine the feasibility, safety and blood pressure lowering effect of BNP so as to identify the optimal dose. |
| Subcutaneous placebo | Placebo comparator | Drug: PlaceboPatients will receive subcutaneously administered placebo twice daily for two days for determination of the effect of BNP. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NesiritideAlso: Natrecor, BNPThis intervention is designed to determine the optimal dose range of BNP for treatment of patients with uncontrolled hypertension | Drug | Subcutaneous BNP |
| PlaceboAlso: Saline solutionFor comparison to elucidate the true effect of nesiritide | Drug | Subcutaneous placebo |
Primary outcome
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.
Office blood pressure and ambulatory blood pressure monitoring (ABPM) recordings will be used for the analysis
3 secondary outcomes
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Cataliotti, MD, PhD principal investigator
Oslo University Hospital and University of Oslo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nesiritide in people with Hypertension, run by Oslo University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Cataliotti, MD, PhD (+47 23016807, alessandro.cataliotti@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.