Heart FailurePhase 4IvaCRTNCT02166060
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
A Phase 4 study testing Ivabradine in people with Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing. The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ivabradine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2014to Oct 2016
- 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
- heart failure NYHA II-IV
- left ventricular ejection fraction =<35%
- CRT-D implanted over 3 months ago
- optimal CRT-D parameters
- biventricular pacing <95% despite the optimal parameters of the device
- optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage
- heart rate at rest below 70 bpm
- over 50% of heart rhythm over 70 bpm at interrogation with the device
Who cannot join
- persistent atrial fibrillation/flutter
- device associated ineffective resynchronization
- contraindications to ivabradine
Trial locations and contacts
1 site in 1 country.
Poland1 site
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Marcin Grabowski, MD
About this study
The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.
The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.
Read the detailed description
Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.
Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.
According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest >70.
The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and >50% of heart rate in device memory >70.
- Conditions
- Heart Failure
- Being tested
- Ivabradine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Procoralan
Ivabradine 5 mg twice a day or 7,5 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Experimental | Ivabradine 5 mg twice a day or 7,5 mg twice a day Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of biventricular pacing >95%
Measured: 6 months
Secondary outcomes (7)
Percentage of biventricular pacing >98%
Measured: 6 months
Time to first inappropriate shock
Measured: 6 months
change of mean heart rate compared with baseline
Measured: 6 months
Cardiovascular hospitalization
Measured: 6 months
The change between baseline and final echocardiographic parameters
Measured: 6 months
The assessment of quality of life (SF36)
Measured: 6 months
The change between baseline and final NYHA class
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (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.
- More trials run by Medical University of WarsawThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Grabowski, Medical University of Warsaw
- Investigators
- Marcin Grabowski, MD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166060
- Sponsor's protocol ID
- IvaCRT KB/111/2014
- Acronym
- IvaCRT
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT02166060
- Acronym / sponsor ID
- IvaCRT / IvaCRT KB/111/2014
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- 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 purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.
The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.
Detailed description
Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.
Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.
According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest >70.
The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and >50% of heart rate in device memory >70.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: IvabradineIvabradine 5 mg twice a day or 7,5 mg twice a day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- heart failure NYHA II-IV
- left ventricular ejection fraction =<35%
- CRT-D implanted over 3 months ago
- optimal CRT-D parameters
- biventricular pacing <95% despite the optimal parameters of the device
Key exclusion criteria (3 listed)
- persistent atrial fibrillation/flutter
- device associated ineffective resynchronization
- contraindications to ivabradine
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 5 mg twice a day or 7,5 mg twice a day | Drug | Ivabradine |
Primary outcome
Percentage of biventricular pacing >95%
Time frame: 6 months
7 secondary outcomes
Percentage of biventricular pacing >98%
Time frame: 6 months
Time to first inappropriate shock
Time frame: 6 months
change of mean heart rate compared with baseline
Time frame: 6 months
Cardiovascular hospitalization
Time frame: 6 months
The change between baseline and final echocardiographic parameters
Time frame: 6 months
The assessment of quality of life (SF36)
Time frame: 6 months
The change between baseline and final NYHA class
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Marcin Grabowski, MD study chair
Medical University of Warsaw
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 Ivabradine in people with Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
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 8 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 18 Jun 2014. 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 Poland. 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 Marcin Grabowski, PhD (+48 660 751 816, marcin.grabowski@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of biventricular pacing >95% (time frame: 6 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 18 Jun 2014.