Inappropriate Sinus TachycardiaPhase 3CIBISTNCT01657136

Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia

A Phase 3 study testing Ivabradine and Beta blocker in people with Inappropriate Sinus Tachycardia, run by Policlinico Casilino ASL RMB at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inappropriate Sinus Tachycardia
What is being tested?: Ivabradine and Beta blocker
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteItaly
Study dates: Sep 2013to Sep 2016
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

Inappropriate sinus tachycardia (HR >100 bpm at rest ECG and/or medium Holter ECG HR >90 bpm)
Age > 18 years;

Who cannot join

Secondary causes of sinus tachycardia;
Structural heart diseases,
Postural orthostatic tachycardia syndrome;
Sinus nodal reentrant tachycardia;
Contraindications to beta-blockers;
Administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class I and III anti-arrhythmic drugs or digitalis at the time of enrollment;
Age < 18 years;
Inability of giving informed consent;

Trial locations and contacts

1 site in 1 country.

Italy1 site

Policlinico Casilino
Rome, Rome, 00169

Other trials in Italy

About this study

Official title: Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia

The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.

Read the detailed description

Inappropriate sinus tachycardia (IST) is a non-paroxysmal arrhythmia, characterized by a persistently high sinus heart rate (HR) and/or an exaggerated HR response to minimal exertion, and can be responsible for palpitations, asthenia, chest pain, dizziness and syncope, which can be highly invalidating. Conventional treatment of IST, targeted to symptoms control, mainly consists on β-blockers. However, these drugs are often insufficient or not well tolerated because of side effects (mostly hypotension) that usually limit the administered dose. Ivabradine, a sinus rate lowering agent currently employed in Europe in the treatment of stable angina and chronic heart failure, has recently been demonstrated to be effective and safe in the treatment of IST by a few case reports and clinical trials. A randomized clinical trial comparing ivabradine to β-blockers has not be performed yet.

Conditions: Inappropriate Sinus Tachycardia
Being tested: Ivabradine, Beta blocker
Keywords: Inappropriate sinus tachycardia, ivabradine, beta blockers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IvabradineDrug
comparison of different drugs
Beta blockerDrug
comparison of different drugs

Study groups in NCT01657136
Study group	Role	What they receive
Ivabradine	Active comparator	Ivabradine will be initiated at a dose of 5 mg twice daily. Dosage should be augmented up to 7.5 mg twice daily in case of symptoms persistence and/or HR > 85 bpm at rest ECG and eventually lowered up to 2.5 mg twice daily in the presence of side effects (phosphenes, diplopia and symptomatic bradycardia). Receives: Drug: Ivabradine
Beta blocker (Bisoprololo)	Active comparator	Bisoprololo will be initiated at a single dose of 5 mg daily. Dosage should be augmented up to 10 mg single dose daily in case of symptoms persistence and/or HR > 85 bpm at rest ECG and eventually lowered up to 2,5 mg single dose daily in the presence of side effects (symptomatic bradycardia, hypotension). Receives: Drug: Beta blocker

What is being measured

The primary outcome is the main question the study is designed to answer.

heart rate reduction
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
Measured: three months
heart rate reduction
Percentage of maximal HR reduction at stress-test ECG
Measured: three months

Secondary outcomes (2)

physical tolerance and quality of life
Improvement of stress-tolerance (maximal load reached at stress test ECG)
Measured: three months
physical tolerance and quality of life
Improvement of the quality of life (Minnesota QoL questionnaire)
Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Sep 2016

First posted6 Aug 2012 (estimated)
Study startSep 2013
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Inappropriate Sinus TachycardiaStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01657136
Sponsor's protocol ID: Casilino0001
Other IDs: 0001
Acronym: CIBIST
Status last verified: Sep 2016
First submitted: 30 Jul 2012
Last updated: 30 Sep 2016
Results posted: No
Data monitoring committee: No

Publications

Calo L, Rebecchi M, Sette A, Martino A, de Ruvo E, Sciarra L, De Luca L, Zuccaro LM, Giunta G, Ciccaglioni A, Lioy E, Fedele F. Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia. Heart Rhythm. 2010 Sep;7(9):1318-23. doi: 10.1016/j.hrthm.2010.05.034. Epub 2010 Jun 1.
PubMed 20621618
Ptaszynski P, Kaczmarek K, Ruta J, Klingenheben T, Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2013 Jan;15(1):116-21. doi: 10.1093/europace/eus204. Epub 2012 Jul 6.
PubMed 22772053

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
RecruitingObservational study
Inappropriate Sinus Tachycardia Registry
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
Not yet recruiting
Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Cardiac Dysautonomia

All Inappropriate Sinus Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
ClinicalTrials.gov ID: NCT01657136
Acronym / sponsor ID: CIBIST / Casilino0001
Conditions: Inappropriate Sinus Tachycardia
Keywords: Inappropriate sinus tachycardia, ivabradine, beta blockers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Policlinico Casilino ASL RMBUniversity, hospital or other
Study start: Sep 2013
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 6 Aug 2012 (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 aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ivabradine	Active comparator	Drug: IvabradineIvabradine will be initiated at a dose of 5 mg twice daily. Dosage should be augmented up to 7.5 mg twice daily in case of symptoms persistence and/or HR > 85 bpm at rest ECG and eventually lowered up to 2.5 mg twice daily in the presence of side effects (phosphenes, diplopia and symptomatic bradycardia).
Beta blocker (Bisoprololo)	Active comparator	Drug: Beta blockerBisoprololo will be initiated at a single dose of 5 mg daily. Dosage should be augmented up to 10 mg single dose daily in case of symptoms persistence and/or HR > 85 bpm at rest ECG and eventually lowered up to 2,5 mg single dose daily in the presence of side effects (symptomatic bradycardia, hypotension).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Inappropriate sinus tachycardia (HR >100 bpm at rest ECG and/or medium Holter ECG HR >90 bpm)
Age > 18 years;

Key exclusion criteria (8 listed)

Secondary causes of sinus tachycardia;
Structural heart diseases,
Postural orthostatic tachycardia syndrome;
Sinus nodal reentrant tachycardia;
Contraindications to beta-blockers;

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
Ivabradinecomparison of different drugs	Drug	Ivabradine
Beta blockercomparison of different drugs	Drug	Beta blocker (Bisoprololo)

Primary outcome

heart rate reduction
Time frame: three months
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
heart rate reduction
Time frame: three months
Percentage of maximal HR reduction at stress-test ECG

2 secondary outcomes

physical tolerance and quality of life
Time frame: three months
physical tolerance and quality of life
Time frame: three months

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 30 Sep 2016.
Background: PubMed 20621618Calo L, Rebecchi M, Sette A, Martino A, de Ruvo E, Sciarra L, De Luca L, Zuccaro LM, Giunta G, Ciccaglioni A, Lioy E, Fedele F. Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia. Heart Rhythm. 2010 Sep;7(9):1318-23. doi: 10.1016/j.hrthm.2010.05.034. Epub 2010 Jun 1.
Background: PubMed 22772053Ptaszynski P, Kaczmarek K, Ruta J, Klingenheben T, Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2013 Jan;15(1):116-21. doi: 10.1093/europace/eus204. Epub 2012 Jul 6.

Related trials for Inappropriate Sinus Tachycardia

Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
RecruitingObservational study
Inappropriate Sinus Tachycardia Registry
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
Not yet recruiting
Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Cardiac Dysautonomia

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.

Leonardo Calò, FESC MD principal investigator

Policlinico Casilino

1 site 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 and Beta blocker in people with Inappropriate Sinus Tachycardia, run by Policlinico Casilino ASL RMB 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 8 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 30 Sep 2016. 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 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?

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?

heart rate reduction (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01657136, which also lists 2 linked publications.

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 30 Sep 2016.