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ISRCTN
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ISRCTN87590288
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ClinicalTrials.gov identifier
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Public title
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The effect of ivabradine on hemodynamics in patients with chronic heart failure
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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EudraCT number 2010-024553-37
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Study hypothesis
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Symptoms of CHF and hemodynamics (measured by echocardiogram [ECHO]) will be improved in CHF patients who receive ivabradine versus patients that receive standard pharmacotherapy.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Non-blinded prospective study
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Countries of recruitment
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Czech Republic
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Disease/condition/study domain
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Chronic heart failure
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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15/04/2011
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Anticipated end date
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31/12/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30-50
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Number of patients with good response to ivabradine therapy
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Sources of funding
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Faculty Hospital Olomouc (Czech Republic)
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Trial website
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Publications
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Contact name
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Dr
Marie
Lazarova
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Address
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Cardiology Department
Faculty Hospital Olomouc
I.P.Pavlova 6
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City/town
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Olomouc
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Zip/Postcode
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775 20
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Country
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Czech Republic
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Sponsor
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Faculty Hospital Olomouc (Czech Republic)
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Address
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I.P. Pavlova 6
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City/town
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Olomouc
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Zip/Postcode
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775 20
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Country
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Czech Republic
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Date applied
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18/03/2011
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Last edited
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04/01/2012
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Date ISRCTN assigned
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04/01/2012
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