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The effect of ivabradine on hemodynamics in patients with chronic heart failure

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87590288
Enrollment
50
Registered
2012-01-04
Start date
2011-04-15
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure Circulatory System Ischaemic cardiomyopathy

Interventions

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

Sponsors

Faculty Hospital Olomouc (Czech Republic)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Number of patients with good response to ivabradine therapy

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026