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]
Secondary outcomes: [3 months]
|
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