Heart Failure With Reduced Ejection FractionIvabradineNCT03701880
Early Use of Ivabradine in Heart Failure
A study testing Ivabradine and Bisoprolol in people with Heart Failure With Reduced Ejection Fraction and Decompensated Heart Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Decompensated Heart Failure
- What is being tested?
- Ivabradine and Bisoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2018to 23 Dec 2019
- Phase
- Interventional
- 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
- Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
- Patients > 18 years old
- Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
- Clinically stable 24-48 hours after admission
- Sinus rhythm with heart rate above 70 bpm
- No previous treatment with ivabradine
Who cannot join
- Patients less than 18 years.
- Arterial fibrillation before inclusion.
- Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock
- 5. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.
Read the detailed description
this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.
The objectives include the following:
- Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
- NYHA class
- Pro-NT-BNP serum level, ST2 serum level
- Echocardiography (left ventricular ejection fraction)
- Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months
- Being tested
- Ivabradine, Bisoprolol
- Keywords
- Decompensated Heart Failure, Ivabradine, ST2 Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Procoralan
Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential
BisoprololDrug
Also called concor
Bisoprolol is beta-blocker
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine group | Experimental | an initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least <70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit. Receives: Drug: Ivabradine; Drug: Bisoprolol |
| Control group | Active comparator | beta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased. Receives: Drug: Ivabradine; Drug: Bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Pro-BNP level
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
Measured: 3 months
Secondary outcomes (6)
ST2 serum level
Repeated ST2 measurements appeared to be a strong predictor of outcome especially in patients with acute HF. Also, ST2 levels in patients with acute HF are significantly higher than in patients with chronic HF and fall rapidly over days to weeks during HF treatment. This lack of reduction in ST2 level during acute HF treatment is predictive of mortality. So, persistently high levels of ST2 were associated with increased mortality risk
Measured: 3 months
The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire
The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. it is simply scored by summation of all 21 responses.The simple sum of the responses that ranges from 0 to 105 is a measurement of heart failure severity as indicated by its adverse effect on the respondent's life during the past month
Measured: 3 months of follow-up.
NYHA class assessment
This classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath
Measured: 3 months
Heart rate
Measuring heart rate
Measured: 3 months
Left ventricular ejection fraction assessment
Two-dimensional echocardiogram coupled with Doppler flow studies will be performed
Measured: 3 months
Blood pressure
Measuring systolic and diastolic blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start16 Sep 2018
- Primary completion23 Dec 2019 (estimated)
- Study completion23 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Sadat City University
- Responsible party
- Principal investigator, Nouran Ahmed Aly, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701880
- Sponsor's protocol ID
- ClinicalPH110
- Acronym
- Ivabradine
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03701880
- Acronym / sponsor ID
- Ivabradine / ClinicalPH110
- Keywords
- Decompensated Heart Failure, Ivabradine, ST2 Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Sadat City University
- Study start
- 16 Sep 2018 (actual)
- Primary completion
- 23 Dec 2019 (estimated)
- Study completion
- 23 Dec 2019 (estimated)
- First posted
- 10 Oct 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 aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.
Detailed description
this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.
The objectives include the following:
- Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
- NYHA class
- Pro-NT-BNP serum level, ST2 serum level
- Echocardiography (left ventricular ejection fraction)
- Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine group | Experimental | Drug: Ivabradine, Drug: Bisoprololan initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least <70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit. |
| Control group | Active comparator | Drug: Ivabradine, Drug: Bisoprololbeta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
- Patients > 18 years old
- Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
- Clinically stable 24-48 hours after admission
- Sinus rhythm with heart rate above 70 bpm
Key exclusion criteria (4 listed)
- Patients less than 18 years.
- Arterial fibrillation before inclusion.
- Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock
- 5. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure
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: ProcoralanIvabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential | Drug | Control group, Ivabradine group |
| BisoprololAlso: concorBisoprolol is beta-blocker | Drug | Control group, Ivabradine group |
Primary outcome
serum Pro-BNP level
Time frame: 3 months
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
6 secondary outcomes
ST2 serum level
Time frame: 3 months
The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire
Time frame: 3 months of follow-up.
NYHA class assessment
Time frame: 3 months
Heart rate
Time frame: 3 months
Left ventricular ejection fraction assessment
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivabradine and Bisoprolol in people with Heart Failure With Reduced Ejection Fraction and Decompensated Heart Failure, run by Ain Shams University at 1 site in Egypt.
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 4 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 11 Oct 2018. 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 Egypt. 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.
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?
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?
serum Pro-BNP level (time frame: 3 months). 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 11 Oct 2018.