NCT01699776

Brief Summary

It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in patients with heart failure, especially in the presence of atrial fibrillation (AF). It is the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart failure was compared. Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with preserved left ventricular systolic function were treated with digoxin and ivabradine for 3 months, according to a randomization cross-over design. Collected data Medical history, physical examination, laboratory (including proBNP and serum digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi, e/e1 ratio).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4

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

Study Start

First participant enrolled

April 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
Last Updated

November 11, 2013

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

September 12, 2012

Last Update Submit

November 8, 2013

Conditions

Cardiac Failure

Keywords

DigoxinIvabradinewith atrial fibrillation.

Outcome Measures

Primary Outcomes (1)

  • Comparative therapeutic effect.

    Effects on symptoms and signs of cardiac failure.

    6 months

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

Ivabradine, 7,5 mg b.id. by mouth for 14-16 weeks.

Drug: Ivabradine

Digoxin

ACTIVE COMPARATOR

Digoxin 0.125 mg once a day, 5 times per week, for 12-14 weeks by mouth.

Drug: Digoxin

Interventions

IvabradineDRUG

7.5 my b.id. by mouth for 12-14 weeks

Also known as: Procoralan
Ivabradine
DigoxinDRUG

1.25 mg once a day by mouth, for 12-14 weeks.

Digoxin

Eligibility Criteria

Age60 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients had heart failure NYHA (New York Heart Association) class III. All had chronic and stable coronary artery disease which had been treated with percutaneous dilatation and stenting, and/or aortocoronary bypass. The pathology had induced a permanent AF and heart failure with left ventricular diastolic dysfunction and preserved systolic function. Preserved systolic function was defined by a LVEF (left ventricular ejection fraction) ≥52%. Left ventricular diastolic dysfunction was defined by a e/e1 ratio \> 15 (septal spectral tissue-Doppler).

You may not qualify if:

  • Unstable myocardial ischemia, reduced systolic cardiac function (LVEF\<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology office

Rheinfelden, Canton of Aargau, CH-4310, Switzerland

Location

Related Publications (1)

  • Cocco G, Jerie P. Comparison between ivabradine and low-dose digoxin in the therapy of diastolic heart failure with preserved left ventricular systolic function. Clin Pract. 2013 Nov 4;3(2):e29. doi: 10.4081/cp.2013.e29. eCollection 2013 Aug 2.

    PMID: 24765517RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

IvabradineDigoxin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Giuseppe Cocco, MD

    Cardiologist, senior lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., FESC

Study Record Dates

First Submitted

September 12, 2012

First Posted

October 4, 2012

Study Start

April 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 11, 2013

Record last verified: 2012-10

Locations

CH(1)