The effect of ivabradine on hemodynamics in patients with chronic heart failure
| ISRCTN | ISRCTN87590288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87590288 |
- Submission date
- 18/03/2011
- Registration date
- 04/01/2012
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marie Lazarova
Scientific
Scientific
Cardiology Department
Faculty Hospital Olomouc
I.P.Pavlova 6
Olomouc
775 20
Czech Republic
Study information
| Study design | Non-blinded prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure | 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 study start date | 15/04/2011 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30-50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/04/2011 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Cardiology Department
Olomouc
775 20
Czech Republic
775 20
Czech Republic
Sponsor information
Faculty Hospital Olomouc (Czech Republic)
Hospital/treatment centre
Hospital/treatment centre
I.P. Pavlova 6
Olomouc
775 20
Czech Republic
"ROR" |
https://ror.org/01jxtne23 |
|---|
Funders
Funder type
University/education
Faculty Hospital Olomouc (Czech Republic)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/01/2019: The following changes have been made:
1. The overall trial status has been changed to 'stopped'.
2. EudraCT number 2010-024553-37 has been removed.
