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

Not Applicable

Completed

• Conditions: Chronic heart failure; Circulatory System; Ischaemic cardiomyopathy

• Registration Number: ISRCTN87590288
• Lead Sponsor: Faculty Hospital Olomouc (Czech Republic)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Study Completion: 2015-12-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Improvement of quality of life<br> 2. Peak oxygen consumption<br> 3. New York Heart Association (NYHA) class improvement<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
umber of patients with good response to ivabradine therapy