Coronary Heart DiseasePhase 4NCT01425164
Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol
A Phase 4 study testing Ivabradine and Carvedilol in people with Coronary Heart Disease and Angina, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Angina, Hemodialysis
- What is being tested?
- Ivabradine and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Jun 2012
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented CAD evidenced by either coronary angiography (>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
- transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry
Who cannot join
- unstable angina pectoris
- myocardial infarction or coronary revascularization within 3 months of study entry
- an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression >0.5 mm, QRS duration >0.1 second, R-wave amplitude <8 mm,preexcitation,or atrial fibrillation)
- inability to undergo exercise testing
- uncontrolled hypertension
- other serious condition (medical, psychiatric, cognitive, or social)
Show all 9Show fewer
- symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates
- heart failure
- greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Chair of Cardiology Second University of Naples
Naples, 80100
About this study
Official title: Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.
- Conditions
- Coronary Heart Disease, Angina, Hemodialysis
- Being tested
- Ivabradine, Carvedilol
- Keywords
- hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine
- Medical subject headings
- Coronary Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
ivabradine tablets, 5 to 7.5 mg bis-in-die.
CarvedilolDrug
carvedilol tablets, 12.5 to 25 mg bis-in-die.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Active comparator | Not described Receives: Drug: Carvedilol |
| Ivabradine | Experimental | Not described Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Principal investigator, Gennaro Cice, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Cice, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425164
- Sponsor's protocol ID
- IVA-ISCHEMIA
- Status last verified
- Jun 2012
- First submitted
- 10 Aug 2011
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT01425164
- Acronym / sponsor ID
- IVA-ISCHEMIA
- Conditions
- Coronary Heart Disease, Angina, Hemodialysis
- Keywords
- hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 29 Aug 2011 (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.
In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.
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 |
|---|---|---|
| Carvedilol | Active comparator | Drug: Carvedilol |
| Ivabradine | Experimental | Drug: Ivabradine |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- documented CAD evidenced by either coronary angiography (>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
- transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry
Key exclusion criteria (9 listed)
- unstable angina pectoris
- myocardial infarction or coronary revascularization within 3 months of study entry
- an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression >0.5 mm, QRS duration >0.1 second, R-wave amplitude <8 mm,preexcitation,or atrial fibrillation)
- inability to undergo exercise testing
- uncontrolled hypertension
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 tablets, 5 to 7.5 mg bis-in-die. | Drug | Ivabradine |
| Carvedilolcarvedilol tablets, 12.5 to 25 mg bis-in-die. | Drug | Carvedilol |
Primary outcome
event-free survival
Time frame: 18 months
primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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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.
Gennaro Cice, MD principal investigator
University of Campania Luigi Vanvitelli
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 and Carvedilol in people with Coronary Heart Disease and Angina, run by University of Campania Luigi Vanvitelli 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 2 inclusion and 9 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 28 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gennaro Cice, MD (+390815666642, gennarocice@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: 18 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 28 Jun 2012.