NCT02046044

Brief Summary

Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.

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
60

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4 heart-failure

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

January 20, 2014

Last Update Submit

January 23, 2014

Conditions

Heart Failure

Keywords

Heart failureDigoxinIvabradine

Outcome Measures

Primary Outcomes (1)

  • Cardiac function and functional status and biochemical parameters

    Cardiac function (echocardiography): Systolic function (left ventricular ejection fraction) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave, left atrium volume index) Maximal oxygen consumption will be evaluated with cardiopulmonary exercise testing Changes in proBNP level (serum value) after treatment

    After 6 months

Secondary Outcomes (4)

  • Cardiovascular mortality

    Up to 6 months

  • All cause mortality

    Up to 6 months

  • Hospital admission for worsening heart failure

    Up to 6 months

  • Heart rate and blood pressure

    After 6 months

Other Outcomes (1)

  • Hospitalization for a cardiovascular reason

    Up to 6 months

Study Arms (2)

Ivabradine

EXPERIMENTAL

Ivabradine: initial dose of 5 mg b.id. dose up-titration to 7,5 mg b.id. in 2 weeks due to the heart rate and maintaining the last dose during 6 months.

Drug: Ivabradine

Digoxin

EXPERIMENTAL

Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.

Drug: Digoxin

Interventions

DigoxinDRUG
Digoxin
IvabradineDRUG
Ivabradine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
  • Sinus rhythm with heart rate of 70 beats per minute or higher
  • Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV

You may not qualify if:

  • Chronic renal failure with glomerular filtration rate \<30 ml/min
  • Atrial fibrillation
  • Pace maker rhythm
  • Advanced stage chronic obstructive lung disease
  • Comorbidity with expected survival below 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

DigoxinIvabradine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kurtulus Karauzum, MD

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurtulus Karauzum, MD

CONTACT

90 555 726 87 90kurtuluskarauzum@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kurtulus Karauzum

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

TU(1)