Angina Pectoris, StablePhase 4NCT03866395
Effects of Ivabradine on Residual Myocardial Ischemia After PCI
A Phase 4 study testing Ivabradine in people with Angina Pectoris, Stable, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris, Stable
- What is being tested?
- Ivabradine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2015to 7 Mar 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
- percutaneous revascularization with stent implantation at least one;
- signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
- ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
- good acoustic window;
- age ≥ 18 years.
Who cannot join
- drugs intolerance or hypersensitivity
- EF ≤ 40 %
- NYHA class III to IV;
- CCS IV
- atrial fibrillation or flutter
- presence of a pacemaker or implantable defibrillator
Show all 15Show fewer
- II or III degree AV block
- HR ≤ 70 bpm at rest or sick sinus syndrome
- any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;
- rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval
- symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
- severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)
- electrolyte disorders
- uncontrolled thyroid disease
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ivabradine on Residual Myocardial Ischemia After PCI Evaluated by Stress Echocardiography
This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.
Read the detailed description
BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.
METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.
- Conditions
- Angina Pectoris, Stable
- Being tested
- Ivabradine
- Keywords
- Stable angina, coronary artery diseases, heart rate, exercise tolerability, diastolic function, ivabradine
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Procoralan, Corlentor
Ivabradine 5 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | drug therapy according to the guidelines |
| Ivabradine Group | Experimental | drug therapy according to the guidelines + Ivabradine 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.
Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Measured: 30 days
Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec)
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Measured: 30 days
chronotropic reserve (unit of measure: beats per minute)
difference between resting heart rate and maximum heart rate at peak exercise
Measured: 30 days
muscular work (unit of measure: watt)
These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Measured: 30 days
Secondary outcomes (4)
diastolic function: PW Doppler E wave (unit of measure: cm/sec)
ventricular filling echocardiographic parameter
Measured: 30 days
diastolic function: TDI derived E' measurements (unit of measure: cm/sec)
ventricular filling echocardiographic parameter. Mitral annular E' velocity was estimated as the average between lateral and septal velocity.
Measured: 30 days
diastolic function: PW Doppler A wave (unit of measure: cm/sec)
ventricular filling echocardiographic parameter
Measured: 30 days
E/E' ratio
ventricular filling echocardiographic parameter. TDI derived E' measurements (unit of measure: cm/sec). PW Doppler E wave (unit of measure: cm/sec)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start5 Mar 2015
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina Pectoris, StableStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Mancone, Azienda Policlinico Umberto I
- Investigators
- Massimo Mancone, Principal investigator, Department of Cardiovascular disease, Sapienza, University of Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866395
- Sponsor's protocol ID
- 04091990
- Status last verified
- Mar 2019
- First submitted
- 1 Jun 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ivabradine on Residual Myocardial Ischemia After PCI Evaluated by Stress Echocardiography
- ClinicalTrials.gov ID
- NCT03866395
- Acronym / sponsor ID
- 04091990
- Conditions
- Angina Pectoris, Stable
- Keywords
- Stable angina, coronary artery diseases, heart rate, exercise tolerability, diastolic function, ivabradine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 7 Mar 2019 (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.
This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.
Detailed description
BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.
METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –drug therapy according to the guidelines |
| Ivabradine Group | Experimental | Drug: Ivabradinedrug therapy according to the guidelines + Ivabradine 5 mg twice a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
- percutaneous revascularization with stent implantation at least one;
- signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
- ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
- good acoustic window;
Key exclusion criteria (15 listed)
- drugs intolerance or hypersensitivity
- EF ≤ 40 %
- NYHA class III to IV;
- CCS IV
- atrial fibrillation or flutter
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: Procoralan, CorlentorIvabradine 5 mg twice a day | Drug | Ivabradine Group |
Primary outcome
Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
Time frame: 30 days
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec)
Time frame: 30 days
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
chronotropic reserve (unit of measure: beats per minute)
Time frame: 30 days
difference between resting heart rate and maximum heart rate at peak exercise
muscular work (unit of measure: watt)
Time frame: 30 days
These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
4 secondary outcomes
diastolic function: PW Doppler E wave (unit of measure: cm/sec)
Time frame: 30 days
diastolic function: TDI derived E' measurements (unit of measure: cm/sec)
Time frame: 30 days
diastolic function: PW Doppler A wave (unit of measure: cm/sec)
Time frame: 30 days
E/E' ratio
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Massimo Mancone principal investigator
Department of Cardiovascular disease, Sapienza, University of Rome, Italy
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 Angina Pectoris, Stable, run by Azienda Policlinico Umberto I at 1 site in Italy.
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 15 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: finished, as of the sponsor's last update on 7 Mar 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg) (time frame: 30 days). The study lists 4 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 7 Mar 2019.