NCT03701880

Brief Summary

The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 16, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

October 8, 2018

Last Update Submit

October 9, 2018

Conditions

Heart Failure With Reduced Ejection FractionDecompensated Heart Failure

Keywords

Decompensated Heart FailureIvabradineST2 Biomarker

Outcome Measures

Primary Outcomes (1)

  • serum Pro-BNP level

    Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF

    3 months

Secondary Outcomes (6)

  • ST2 serum level

    3 months

  • The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire

    3 months of follow-up.

  • NYHA class assessment

    3 months

  • Heart rate

    3 months

  • Left ventricular ejection fraction assessment

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Ivabradine group

EXPERIMENTAL

an initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least \<70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit.

Drug: IvabradineDrug: Bisoprolol

Control group

ACTIVE COMPARATOR

beta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased.

Drug: IvabradineDrug: Bisoprolol

Interventions

IvabradineDRUG

Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential

Also known as: Procoralan
Control groupIvabradine group
BisoprololDRUG

Bisoprolol is beta-blocker

Also known as: concor
Control groupIvabradine group

Eligibility Criteria

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

You may qualify if:

  • Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
  • Patients \> 18 years old
  • Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
  • Clinically stable 24-48 hours after admission
  • Sinus rhythm with heart rate above 70 bpm
  • No previous treatment with ivabradine

You may not qualify if:

  • Patients less than 18 years.
  • Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock
  • \. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Demerdash Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

IvabradineBisoprolol

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant of Clinical Pharmacy department

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

September 16, 2018

Primary Completion

December 23, 2019

Study Completion

December 23, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

EG(1)