High Heart RatePhase 4NCT01364077
Ivabradine in Hemodialysed Patients With Increased Heart Rate
A Phase 4 study testing Ivabradine in people with High Heart Rate, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Heart Rate
- What is being tested?
- Ivabradine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jan 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis patients
- Sinus rhythm
- Pre-dialytic Heart rate > 80 bpm
Who cannot join
- Atrial fibrillation/atrial flutter
- Heart failure
- Valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.
Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.
Read more
Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.
Aim:
To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)
- Conditions
- High Heart Rate
- Being tested
- Ivabradine, Placebo
- Keywords
- Heart rate, Dialysis, ESRD, ivabradine
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Not described Receives: Drug: Ivabradine |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: 1 year
Secondary outcomes (1)
Number of patients that experienced hypotension
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Heart RateStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Cice, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Cice, MD, Principal investigator, Second Univesity of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364077
- Sponsor's protocol ID
- IV-DIAL.01
- Other IDs
- IV-DIAL.01-A
- Status last verified
- Jun 2012
- First submitted
- 25 May 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
- ClinicalTrials.gov ID
- NCT01364077
- Acronym / sponsor ID
- IV-DIAL.01
- Conditions
- High Heart Rate
- Keywords
- Heart rate, Dialysis, ESRD, ivabradine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- First posted
- 2 Jun 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.
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.
Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.
Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.
Aim:
To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)
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 |
|---|---|---|
| Ivabradine | Active comparator | Drug: Ivabradine |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dialysis patients
- Sinus rhythm
- Pre-dialytic Heart rate > 80 bpm
Key exclusion criteria (3 listed)
- Atrial fibrillation/atrial flutter
- Heart failure
- Valvular disease
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 5 mg BID titrated to 7.5 mg if tolerated | Drug | Ivabradine |
| PlaceboMatched placebo | Drug | Control |
Primary outcome
Heart rate
Time frame: 1 year
1 secondary outcome
Number of patients that experienced hypotension
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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
Second Univesity of Naples
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 High Heart Rate, 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 3 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 21 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. Some participants in this study may receive a placebo. 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?
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?
Heart rate (time frame: 1 year). 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 21 Jun 2012.