NCT01657136

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

July 30, 2012

Last Update Submit

September 29, 2016

Conditions

Inappropriate Sinus Tachycardia

Keywords

Inappropriate sinus tachycardiaivabradinebeta blockers

Outcome Measures

Primary Outcomes (2)

  • heart rate reduction

    Percentage of HR reduction at Holter ECG (mean, minimal and maximal)

    three months

  • heart rate reduction

    Percentage of maximal HR reduction at stress-test ECG

    three months

Secondary Outcomes (2)

  • physical tolerance and quality of life

    three months

  • physical tolerance and quality of life

    three months

Study Arms (2)

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).

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).

Drug: Beta blocker

Interventions

IvabradineDRUG

comparison of different drugs

Ivabradine
Beta blockerDRUG

comparison of different drugs

Beta blocker (Bisoprololo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Casilino

Rome, Rome, 00169, Italy

Location

Related Publications (2)

  • 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.

    PMID: 20621618BACKGROUND

  • 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.

    PMID: 22772053BACKGROUND

MeSH Terms

Interventions

IvabradineAdrenergic beta-Antagonists

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAdrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Leonardo Calò, FESC MD

    Policlinico Casilino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of clinical arrhythmology and cardiac electrophysiology department

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 6, 2012

Study Start

September 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

IT(1)