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. 2020 Nov 4;2020(11):CD013004. doi: 10.1002/14651858.CD013004.pub2

NCT03701880.

Study name The impact of ivabradine administration on clinical outcome and biomarkers of decompensated heart failure
Methods Study design: Interventional
Allocation: Randomised
Intervention model: Parallel assignment
Masking: None (open‐label)
Primary purpose: Treatment
Unit of randomisation: Not applicable
Total duration of study: No information
Intervention time: 3 months
Follow‐up: No information
Setting: El Demerdash Hospital, Cairo, Egypt
Participants Type of heart failure: HF‐REF, decompensated heart failure
N = 50 participants
Age: > 18 years
Gender: Both males and females
Inclusion criteria:
1. Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilisation
2. Patients > 18 years old
3. Left ventricular ejection fraction less than 40% of presumed irreversible aetiology
4. Clinically stable 24 to 48 hours after admission
5. Sinus rhythm with heart rate above 70 bpm
6. No previous treatment with ivabradine
Exclusion criteria:
1. Patients less than 18 years
2. Arterial fibrillation before inclusion
3. Ventricular dysfunction due to acute event (myocarditis, AMI)
4. Cardiogenic shock
5. Patients are taking drug interact with ivabradine
6. Carrier or candidate for pacemaker, heart transportation, cardiac surgery, or other cardiovascular procedure
Interventions Intervention: Ivabradine 5 to 7.5 mg
Comparison: Bisoprolol 2.5 to 10 mg
Concomitant medications: No information
Excluded medications: No information
Outcomes Outcomes measured in the study:
Primary outcome: [3 months]
  • Serum pro‐BNP level


Secondary outcomes: [3 months]
  • ST2 serum level

  • The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire [3 months of follow‐up]

  • NYHA class assessment

  • Heart rate

  • Left ventricular ejection fraction assessment

  • Blood pressure

Starting date 16 September 2018, not recruiting
Contact information Nouran Ahmed Aly
Teaching Assistant of Clinical Pharmacy Department
Sadat City University
Phone: No information
Email: No information
Notes Primary sponsor: Ain Shams University
Collaborator: Sadat City University
Ethics status: No information

Abbreviations: ACE = Angiotensin‐converting enzyme, ACS = Acute coronary syndrome, ARB = angiotensin receptor blockers, BNP = brain natriuretic peptide, , bpm = beats per minute, COPD = Chronic obstructive pulmonary disease, CHF = chronic heart failure, CRT = Cardiac resynchronization therapy, e´ = Early diastolic mitral annulus velocity, E/A = ratio of peak velocity blood flow from gravity in early diastole to peak velocity flow in late diastole caused by atrial contraction, E/E´= ratio between early mitral inflow velocity and mitral annular early diastolic velocity, ECG = electrocardiogram, EF = ejection fraction, GFR = Glomerular filtration rate, HF = heart failure, HFpEF = heart failure with preserved ejection fraction, HR = heart rate, ICD = implantable cardioverter‐defibrillator, KCCQ = Kansas City Cardiomyopathy Questionnaire, LAVI = Left Atrial Volume Index, LVEF = Left ventricular ejection fraction, max. = maximum, MRI = magnetic resonance imaging, 6MWT = six minute walk test, NT‐pro‐BNP = N‐terminal pro brain natriuretic peptide, NYHA = New York Heart Association, pVO2 = peak oxygen uptake, QT interval = time of ventricular activity including both depolarisation and repolarisation, RV = right ventricular, SBP = systolic blood pressure