Heart FailurePhase 3IVA-CSNCT05594342
Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support
A Phase 3 study testing Ivabradine 7.5Mg Tab and DOBUTamine Injectable Solution in people with Heart Failure and Cardiogenic Shock, run by The Young Investigator Group of Cardiovascular Research at 2 sites in Egypt.
Trial summary
Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiogenic Shock, Ischemic Heart Disease
- What is being tested?
- Ivabradine 7.5Mg Tab and DOBUTamine Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2022to 1 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.
Who cannot join
- Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
- Patients with no oral intake
- Patients who refused to sign the consent
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Andalusia Hospitals
Alexandria, 21521
Haitham Badran, MD, Haithamcardiology@yahoo.com
Abdallah Almaghraby, MSc
- Recruiting
Tiba Hospital
Alexandria, 21521
Abdallah Almaghraby, PhD, dr.maghraby@gmail.com
Abdelrahman Assal, MD
About this study
Official title: Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support
Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
Read the detailed description
Background and study rationale:
Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2
Aim of the work:
- This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
- Design: Randomized open-label interventional clinical trial.
Methods and patients:
- Study Type: Interventional (Clinical Trial)
- Estimated Enrollment: 200 participants
- Allocation: Randomized
- Perspective: Prospective Study
- Intervention Model: Two Group Assignment
- Masking: None (Open Label)
- Primary purpose: Treatment
- Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS)
- Start Date: 01 August 2022
- Estimated Primary Completion Date: 01 January 2023
- Conditions
- Heart Failure, Cardiogenic Shock, Ischemic Heart Disease
- Being tested
- Ivabradine 7.5Mg Tab, DOBUTamine Injectable Solution
- Keywords
- Heart Failure, Cardiogenic shock, Ivabradine
- Medical subject headings
- Heart Failure, Shock, Cardiogenic, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine 7.5Mg TabDrug
Also called Ivabradine
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
DOBUTamine Injectable SolutionDrug
Also called Dobutamine
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine+ dobutamine infusion | Experimental | Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes. Receives: Drug: Ivabradine 7.5Mg Tab; Drug: DOBUTamine Injectable Solution |
| Dobutamine infusion only | Active comparator | Patient will receive dobutamine infusion only for cardiogenic shock Receives: Drug: DOBUTamine Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate reduction
Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Measured: Up to 7 days
Time of weaning from dobutamine infusion
The time needed to completely wean dobutamine infusion calculated in hours
Measured: Up to 7 days
Duration of hospital stay
Total duration of hospital stay calculated in days
Measured: Up to 1 month
Secondary outcomes (2)
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Any ventricular arrhythmias will be documented
Measured: Up to 1 month
Supraventricular arrhythmia
Any supraventricular arrhythmias will be documented
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Jul 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Young Investigator Group of Cardiovascular Research
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Abdallah Almaghraby, The Young Investigator Group of Cardiovascular Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594342
- Sponsor's protocol ID
- YIG-10202201
- Acronym
- IVA-CS
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support
- ClinicalTrials.gov ID
- NCT05594342
- Acronym / sponsor ID
- IVA-CS / YIG-10202201
- Conditions
- Heart Failure, Cardiogenic Shock, Ischemic Heart Disease
- Keywords
- Heart Failure, Cardiogenic shock, Ivabradine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Young Investigator Group of Cardiovascular ResearchResearch network
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 26 Oct 2022 (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.
Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
Detailed description
Background and study rationale:
Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2
Aim of the work:
- This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
- Design: Randomized open-label interventional clinical trial.
Methods and patients:
- Study Type: Interventional (Clinical Trial)
- Estimated Enrollment: 200 participants
- Allocation: Randomized
- Perspective: Prospective Study
- Intervention Model: Two Group Assignment
- Masking: None (Open Label)
- Primary purpose: Treatment
- Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS)
- Start Date: 01 August 2022
- Estimated Primary Completion Date: 01 January 2023
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine+ dobutamine infusion | Experimental | Drug: Ivabradine 7.5Mg Tab, Drug: DOBUTamine Injectable SolutionPatients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes. |
| Dobutamine infusion only | Active comparator | Drug: DOBUTamine Injectable SolutionPatient will receive dobutamine infusion only for cardiogenic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.
Key exclusion criteria (3 listed)
- Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
- Patients with no oral intake
- Patients who refused to sign the consent
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 |
|---|---|---|
| Ivabradine 7.5Mg TabAlso: IvabradinePatients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes. | Drug | Ivabradine+ dobutamine infusion |
| DOBUTamine Injectable SolutionAlso: DobutamineDobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute | Drug | Dobutamine infusion only, Ivabradine+ dobutamine infusion |
Primary outcome
Heart rate reduction
Time frame: Up to 7 days
Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Time of weaning from dobutamine infusion
Time frame: Up to 7 days
The time needed to completely wean dobutamine infusion calculated in hours
Duration of hospital stay
Time frame: Up to 1 month
Total duration of hospital stay calculated in days
2 secondary outcomes
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Time frame: Up to 1 month
Supraventricular arrhythmia
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivabradine 7.5Mg Tab and DOBUTamine Injectable Solution in people with Heart Failure and Cardiogenic Shock, run by The Young Investigator Group of Cardiovascular Research at 2 sites 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 1 inclusion and 3 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah Almaghraby, PhD (+201222851687, dr.maghraby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate reduction (time frame: Up to 7 days). The study lists 3 primary outcomes in all. 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 26 Oct 2022.