Condition category
Circulatory System
Date applied
18/03/2011
Date assigned
04/01/2012
Last edited
04/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marie Lazarova

ORCID ID

Contact details

Cardiology Department
Faculty Hospital Olomouc
I.P.Pavlova 6
Olomouc
775 20
Czech Republic

Additional identifiers

EudraCT number

2010-024553-37

ClinicalTrials.gov number

Protocol/serial number

EudraCT number 2010-024553-37

Study information

Scientific title

The effect of ivabradine versus standard pharmacotherapy on hemodynamics in patients with chronic heart failure (CHF) and the analysis of the possible mechanism of improvement

Acronym

Study hypothesis

Symptoms of CHF and hemodynamics (measured by echocardiogram [ECHO]) will be improved in CHF patients who receive ivabradine versus patients that receive standard pharmacotherapy.

Ethics approval

Not provided at time of registration

Study design

Non-blinded prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic heart failure

Intervention

1. All the patients will be managed with standard CHF therapy: up-titrated beta-blocker dose, angiotensin-converting-enzyme (ACE) inhibitor dose, spironolacton dose
2. Adding diuretics, digoxin if indicated (according to the Czech cardiology association guidelines)
3. As well as non-pharmacologic treatment with Cardiac Resynchronization Therapy Device (CRT-D) according to the current guidelines of Czech cardiology association
4. The patients in the ivabradine group will in addittion have the up-titrated dose of ivabradine to 7.5 mg twice daily, unless they have bradycardia

Intervention type

Drug

Phase

Not Applicable

Drug names

Ivabradine

Primary outcome measures

1. Improvement of quality of life
2. Peak oxygen consumption
3. New York Heart Association (NYHA) class improvement
4. Improvement in hemodynamics (measured in non-invasive way with echocardiography and MRI) in patients with CHF after recieving medication of ivabradine in addittion to standard optimized HF pharmacotherapy

Secondary outcome measures

Number of patients with good response to ivabradine therapy

Overall trial start date

15/04/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged more than 18 years
2. CHF
3. Left ventricular ejection fraction (LVEF) ≤ 40%
4. Sinus rhythm
5. Patients four weeks stabile on maximal tolerated standard CHF pharmacotherapy without acute decompensations
6. Heart rate after 5 minutes resting more than or 70 beats per min measured by ECG
7. Patients indicated to Cardiac Resynchronization Therapy (CRT) will be enrolled after 6 months after implantation
8. Patients who give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30-50

Participant exclusion criteria

1. Permanent atrial fibrillation with the rate control strategy
2. Sick sinus syndrome
3. Sinoatrial block or AV block of III degree without pacemaker
4. Patients with pacemaker/implantable cardioverter defibrillator (ICD) without CRT with more than 40% paced contractions daily
5. Patients less than two months after myocardial infarction (MI)
6. Ivabradine intolerance
7. Severe liver insufficiency
8. Combination with strong CYP3A4 inhibitors such as azol antimycotics (ketokonazol, itrakonazol), makrolid antibiotics (klarithromycin, erythromycin per os, josamycin, telithromycin), inhibitors of HIV proteases (nelfinavir, ritonavir) and nefazodon
9. Other illness which limits patients prognosis of less than two years
10. Women in fertile age without effective contraception
11. Breastfeeding women

Recruitment start date

15/04/2011

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Cardiology Department
Olomouc
775 20
Czech Republic

Sponsor information

Organisation

Faculty Hospital Olomouc (Czech Republic)

Sponsor details

I.P. Pavlova 6
Olomouc
775 20
Czech Republic

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Faculty Hospital Olomouc (Czech Republic)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes