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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

NCT01761825

Postural Tachycardia Syndrome

UNKNOWN PHASE2

Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm

NCT01022463

Mitral Stenosis

COMPLETED PHASE3

Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

NCT06276816

Sinus Bradycardia

RECRUITING

Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

NCT01425164

Coronary Heart Disease Angina Hemodialysis

UNKNOWN PHASE4

Crossover Study of Propranolol vs Ivabradine in POTS

NCT04186286

Postural Tachycardia Syndrome

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inappropriate Sinus Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ivabradine

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).

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

comparison of different drugs

Beta blocker (Bisoprololo)

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).

Group Type ACTIVE_COMPARATOR

Beta blocker

Intervention Type DRUG

comparison of different drugs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ivabradine

comparison of different drugs

Intervention Type DRUG

Beta blocker

comparison of different drugs

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No