Heart Failure NYHA Class IVPhase 4NCT03631654
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
A Phase 4 study testing Ivabradine in people with Heart Failure NYHA Class IV, run by University of Maryland, Baltimore.
Trial summary
Ivabradine, a selective inhibitor of the If current in the sinoatrial node, provides heart rate reduction and leads to a reduction in heart failure hospitalizations. For this reason, the American College of Cardiology (ACC) and the American Heart Association (AHA) guidelines provide a class IIa recommendation for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class IV
- What is being tested?
- Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA Stage D heart failure on 2 weeks of consecutive IV dobutamine or milrinone
- Followed at UMMC outpatient heart failure clinic or admitted to advanced heart failure inpatient service and planning to follow up at UMMC outpatient heart failure clinic
Who cannot join
- Patients who are already on ivabradine
- Patients who are not willing to follow-up with UMMC outpatient heart failure team
About this study
Official title: Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes: A Pilot Study
Ivabradine, a selective inhibitor of the If current in the sinoatrial node, provides heart rate reduction and leads to a reduction in heart failure hospitalizations. For this reason, the American College of Cardiology (ACC) and the American Heart Association (AHA) guidelines provide a class IIa recommendation for ivabradine in stable heart failure patients with LVEF 35% and New York Heart Association (NYHA) class II-III symptoms who are on a beta blocker at maximum tolerated dose with a resting heart rate of 70 beats per minute or greater. While ivabradine leads to improvement in outcomes in stable NYHA class II-III chronic heart failure patients, its role in class IV, stage D heart failure, and cardiogenic shock is less clear.
Ivabradine's effect on acute cardiogenic shock has been evaluated by two recent studies. In the MODIFY trial, a randomized control study evaluating ivabradine in patients with multiorgan dysfunction, the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes. However, a small prospective trial demonstrated a significant decrease in heart rate and NT-proBNP with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine. While few data investigate ivabradine's role in acute cardiogenic shock, it has yet to be studied in heart failure patients on long-term inotropic therapy. Inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias. Moreover, patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates. Ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes.
Read more
Given the benefits of ivabradine in stable chronic heart failure patients, we plan to perform a study investigating the role of ivabradine in NYHA Stage D patients on home inotropes.
Our primary objective is to analyze changes in two cardiac biomarkers, NT-proBNP and high-sensitivity troponin. Our secondary outcomes include changes in noninvasive echocardiographic hemodynamics, changes in arrhythmia burden, and heart failure symptom modification based on 6-minute walk test results.
- Conditions
- Heart Failure NYHA Class IV
- Being tested
- Ivabradine, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine administration--tablets given 5 mg twice daily for 2 weeks, then 7.5 mg twice daily
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Placebos |
| Intervention | Experimental | Not described Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac biomarkers
NT-pro BNP and high sensitivity troponin
Measured: One month
Secondary outcomes (2)
Echocardiogram
ejection fraction (%)
Measured: 2 weeks, and one month
6-minute walk test
Distance walked (meters) in 6 minutes
Measured: 2 weeks, and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Oct 2020 (estimated)
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: Unable to obtain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IVStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Stephen Gottlieb, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631654
- Sponsor's protocol ID
- HP-00080414
- Status last verified
- Dec 2024
- First submitted
- 3 Aug 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes: A Pilot Study
- ClinicalTrials.gov ID
- NCT03631654
- Acronym / sponsor ID
- HP-00080414
- Conditions
- Heart Failure NYHA Class IV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 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.
Ivabradine, a selective inhibitor of the If current in the sinoatrial node, provides heart rate reduction and leads to a reduction in heart failure hospitalizations. For this reason, the American College of Cardiology (ACC) and the American Heart Association (AHA) guidelines provide a class IIa recommendation for ivabradine in stable heart failure patients with LVEF 35% and New York Heart Association (NYHA) class II-III symptoms who are on a beta blocker at maximum tolerated dose with a resting heart rate of 70 beats per minute or greater. While ivabradine leads to improvement in outcomes in stable NYHA class II-III chronic heart failure patients, its role in class IV, stage D heart failure, and cardiogenic shock is less clear.
Ivabradine's effect on acute cardiogenic shock has been evaluated by two recent studies. In the MODIFY trial, a randomized control study evaluating ivabradine in patients with multiorgan dysfunction, the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes. However, a small prospective trial demonstrated a significant decrease in heart rate and NT-proBNP with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine. While few data investigate ivabradine's role in acute cardiogenic shock, it has yet to be studied in heart failure patients on long-term inotropic therapy. Inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias. Moreover, patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates. Ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes.
Given the benefits of ivabradine in stable chronic heart failure patients, we plan to perform a study investigating the role of ivabradine in NYHA Stage D patients on home inotropes.
Our primary objective is to analyze changes in two cardiac biomarkers, NT-proBNP and high-sensitivity troponin. Our secondary outcomes include changes in noninvasive echocardiographic hemodynamics, changes in arrhythmia burden, and heart failure symptom modification based on 6-minute walk test results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebos |
| Intervention | Experimental | Drug: Ivabradine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NYHA Stage D heart failure on 2 weeks of consecutive IV dobutamine or milrinone
- Followed at UMMC outpatient heart failure clinic or admitted to advanced heart failure inpatient service and planning to follow up at UMMC outpatient heart failure clinic
Key exclusion criteria (2 listed)
- Patients who are already on ivabradine
- Patients who are not willing to follow-up with UMMC outpatient heart failure team
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 |
|---|---|---|
| IvabradineIvabradine administration--tablets given 5 mg twice daily for 2 weeks, then 7.5 mg twice daily | Drug | Intervention |
| PlacebosPlacebo | Drug | Control |
Primary outcome
Cardiac biomarkers
Time frame: One month
NT-pro BNP and high sensitivity troponin
2 secondary outcomes
Echocardiogram
Time frame: 2 weeks, and one month
6-minute walk test
Time frame: 2 weeks, and one month
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 12 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine in people with Heart Failure NYHA Class IV, run by University of Maryland, Baltimore.
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 2 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 12 Dec 2024. 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. 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 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?
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?
Cardiac biomarkers (time frame: One month). 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 12 Dec 2024.