Heart Failure, SystolicPhase 4NCT03553303
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
A Phase 4 study testing Sacubitril / Valsartan Oral Tablet in people with Heart Failure, Systolic, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Sacubitril / Valsartan Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 16 Oct 2018to May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must give written informed consent before any study assessment is performed.
- Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
- Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
- Patients on optimized medical treatment for heart failure. -
Who cannot join
- Patients not able to comply in the study.
- Patients having contraindication for treatment with Entresto;
- Hypersensitivity to the active substances or to any of the excipients listed in section
- Hyperkalemia: > 5.4 mmol/L
- Known history of angioedema related to previous ACE inhibitor or ARB therapy.
- Hereditary or idiopathic angioedema.
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- Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73m2)
- End-stage renal disease (<15 mL/min per 1.73m2 or treatment by dialysis).
- Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
- Pregnancy Breast-feeding-
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ringerike Hospital Vestre Viken Hospital Trust
Hønefoss, Buskerud, 3511
Christian Hall, +4747500900
Hall
About this study
Official title: Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.
- Conditions
- Heart Failure, Systolic
- Being tested
- Sacubitril / Valsartan Oral Tablet
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril / Valsartan Oral TabletDrug
Increasing doses of Sacubitril/Valsartan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Increasing doses of Sacubitril/Valsartan Receives: Drug: Sacubitril / Valsartan Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurohormonal plasma concentration
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start16 Oct 2018
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Hall, Oslo University Hospital
- Investigators
- Christian Hall, MD PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553303
- Sponsor's protocol ID
- 3403003
- Status last verified
- Aug 2019
- First submitted
- 23 May 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton
- ClinicalTrials.gov ID
- NCT03553303
- Acronym / sponsor ID
- 3403003
- Conditions
- Heart Failure, Systolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 12 Jun 2018 (actual)
- 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.
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Sacubitril / Valsartan Oral TabletIncreasing doses of Sacubitril/Valsartan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must give written informed consent before any study assessment is performed.
- Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
- Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
- Patients on optimized medical treatment for heart failure. -
Key exclusion criteria (10 listed)
- Patients not able to comply in the study.
- Patients having contraindication for treatment with Entresto;
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 |
|---|---|---|
| Sacubitril / Valsartan Oral TabletIncreasing doses of Sacubitril/Valsartan | Drug | Intervention |
Primary outcome
Neurohormonal plasma concentration
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christian Hall, MD PhD study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril / Valsartan Oral Tablet in people with Heart Failure, Systolic, run by Oslo University Hospital at 1 site 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Hall, MD PhD (+4747500900, chall@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurohormonal plasma concentration (time frame: 8 weeks). 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 29 Aug 2019.