Heart Transplantation, Elevated Resting Heart RatePhase 3NCT03619187
An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients
A Phase 3 study testing Ivabradine in people with Heart Transplantation, Elevated Resting Heart Rate, run by Amgen.
Trial summary
The hypothesis is that the treatment with ivabradine will increase pVO2 after 16 weeks of treatment compared to baseline in the heart transplant recipient population with elevated resting HR. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Transplantation, Elevated Resting Heart Rate
- What is being tested?
- Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2018to 19 Feb 2020
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Male or female, ≥ 18 to ≤ 70 years of age at signing of informed consent
- History of heart transplantation within 1 to 4 years from screening
- Sinus rhythm and elevated resting HR > 95 bpm at screening (ECG)
- Able to perform exercise testing as required per protocol, per the investigator, at time of screening
- Peak VO2 < 70% of the predicted normal value for age and gender with respiratory exchange ratio (RER) ≥ 1.05, from a CPET conducted during screening
Who cannot join
- Participation in a cardiac rehabilitation program during the study period
- Treatment for heart transplant rejection within the previous 3 months before screening
- Severe allograft vasculopathy limiting the tolerance of CPET at time of screening
- During CPET at screening, significant adverse finding (eg, exercise-induced early ischemic changes, abnormal blood pressure response, unexpected arrhythmia or other serious finding) that precludes safe participation in the study, per investigator
- Sick sinus syndrome, sinoatrial block and/or third degree atrioventricular block, unless a functioning demand pacemaker is present, or pacemaker dependency at screening
- Resting systolic blood pressure >160 mmHg or <100 mmHg, or diastolic blood pressure >90 mmHg at screening
Show all 20Show fewer
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Presence of clinically meaningful acute or chronic infection, per investigator, at screening
- Major medical event or procedure (as determined by investigator) within 3 months prior to screening
- Previously received ivabradine after heart transplantation (prior to the participation in this study)
- Subjects taking QT prolonging medicinal products for cardiovascular (eg, but not limited to, quinidine, disopyramide, bepridil, sotalol, ibutilide) or non-cardiovascular disease (eg, but not limited to, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous (IV) erythromycin)
- Subjects should not be receiving beta-blockers, diltiazem, or verapamil for at least 7 days before screening
- Subjects exposed to a strong Cytochrome P450 3A4 (CYP3A4) inhibitor (examples of strong CYP3A4 inhibitors include; azole antifungals [eg, itraconazole], macrolide antibiotics [eg, clarithromycin, telithromycin], human immunodeficiency virus protease inhibitors, [eg, nelfinavir], and nefazodone]) within 14 days prior to screening, or to a strong CYP3A4 inducer (examples of CYP3A4 inducers include; St. John's wort, rifampicin, barbiturates, and phenytoin) within 28 days prior to screening
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Hemoglobin < 8 g/dL at screening (or within 3 months prior to screening if no clinically meaningful event, as determined by the investigator, has occurred in that period) and not expected to receive blood transfusion during the study
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease [MDRD] equation) at screening (or within 3 months prior to screening)
- Subject has known sensitivity to any of the products to be administered during dosing
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 2 weeks after the last dose of investigational product
- Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 2 weeks after the last dose of investigational product. Refer to Section 12.5 for additional contraceptive information
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test
About this study
Official title: A Phase 3, Open-label, Multicenter Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients With Elevated Resting Heart Rate
The hypothesis is that the treatment with ivabradine will increase pVO2 after 16 weeks of treatment compared to baseline in the heart transplant recipient population with elevated resting HR.
Read the detailed description
The primary goal of this study is to assess the impact of ivabradine on cardiopulmonary exercise capacity in heart transplant recipients with elevated resting heart rate (HR).
Exercise capacity will be assessed by the determination of the peak oxygen consumption (pVO2) during standard cardiopulmonary exercise test before and after the treatment period with ivabradine. The secondary goal is to determine HR reduction with ivabradine in the patient population.
- Being tested
- Ivabradine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Corlanor
Ivabradine will be provided in bottles (60 tablets per bottle) labeled ivabradine 5 mg and ivabradine 7.5 mg. The 2.5 mg dose of ivabradine will be achieved by subjects splitting the 5 mg tablets into equal halves.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Study Product Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pVO2
To evaluate the effect of treatment with ivabradine on exercise capacity as measured by peak oxygen consumption (pVO2)
Measured: Week 16
Secondary outcomes (1)
Resting Heart Rate
To evaluate the effect of treatment with ivabradine on resting heart rate (HR)
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start2 Nov 2018 (estimated)
- Primary completion19 Feb 2020 (estimated)
- Study completion19 Feb 2020 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplantation, Elevated Resting Heart RateStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-arm, multicenter study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619187
- Sponsor's protocol ID
- 20180037
- Status last verified
- Nov 2018
- First submitted
- 2 Aug 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Multicenter Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients With Elevated Resting Heart Rate
- ClinicalTrials.gov ID
- NCT03619187
- Acronym / sponsor ID
- 20180037
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2018 (estimated)
- Primary completion
- 19 Feb 2020 (estimated)
- Study completion
- 19 Feb 2020 (estimated)
- First posted
- 7 Aug 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 hypothesis is that the treatment with ivabradine will increase pVO2 after 16 weeks of treatment compared to baseline in the heart transplant recipient population with elevated resting HR.
Detailed description
The primary goal of this study is to assess the impact of ivabradine on cardiopulmonary exercise capacity in heart transplant recipients with elevated resting heart rate (HR).
Exercise capacity will be assessed by the determination of the peak oxygen consumption (pVO2) during standard cardiopulmonary exercise test before and after the treatment period with ivabradine. The secondary goal is to determine HR reduction with ivabradine in the patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-arm, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: IvabradineStudy Product |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Male or female, ≥ 18 to ≤ 70 years of age at signing of informed consent
- History of heart transplantation within 1 to 4 years from screening
- Sinus rhythm and elevated resting HR > 95 bpm at screening (ECG)
- Able to perform exercise testing as required per protocol, per the investigator, at time of screening
Key exclusion criteria (20 listed)
- Participation in a cardiac rehabilitation program during the study period
- Treatment for heart transplant rejection within the previous 3 months before screening
- Severe allograft vasculopathy limiting the tolerance of CPET at time of screening
- During CPET at screening, significant adverse finding (eg, exercise-induced early ischemic changes, abnormal blood pressure response, unexpected arrhythmia or other serious finding) that precludes safe participation in the study, per investigator
- Sick sinus syndrome, sinoatrial block and/or third degree atrioventricular block, unless a functioning demand pacemaker is present, or pacemaker dependency at screening
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 |
|---|---|---|
| IvabradineAlso: CorlanorIvabradine will be provided in bottles (60 tablets per bottle) labeled ivabradine 5 mg and ivabradine 7.5 mg. The 2.5 mg dose of ivabradine will be achieved by subjects splitting the 5 mg tablets into equal halves. | Drug | Single Arm |
Primary outcome
pVO2
Time frame: Week 16
To evaluate the effect of treatment with ivabradine on exercise capacity as measured by peak oxygen consumption (pVO2)
1 secondary outcome
Resting Heart Rate
Time frame: Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivabradine in people with Heart Transplantation, Elevated Resting Heart Rate, run by Amgen.
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 6 inclusion and 20 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: withdrawn, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pVO2 (time frame: Week 16). 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 19 Nov 2018.