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

Tumasyan 2018.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: No information
Run‐in period: No information
Intervention time: No information
Follow‐up: No information
Setting: No information
Participants Type of heart failure: CHF
N = 135 (digoxin: 44; ivabradine: 46; SC: 45)
Mean age: 60.1 years
Gender: No information
Severity of condition: No information
Inclusion criteria:

  • NYHA III‐IV

  • Symptomatic HFmrEF

  • HR > 70 bpm


Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine 15 mg twice a day
Comparison:

  • Digoxin 0.25 mg twice a day

  • Standard care


Concomitant medications:

  • ACE inhibitors

  • BB

  • Diuretics


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, Month 12, 24, and 36]

  • LV, RV, LA, RA atrial parameters

  • NT‐pro‐BNP

  • High sensitivity C‐reactive protein levels

  • Tricuspid annulus annular systolic velocity

  • Tricuspid annulus plane systolic excursion

  • LV mean e´septal and lateral wall

  • Pulmonary artery ejection time

  • RA and LA functional index

  • Pulmonary vein systolic contribution

  • Difference between duration of reversal atrial flow and late transmitral filling


Conclusion:
"1) Changes of Ar‐A = 50%, RAFI and LAFI, s‘, e‘ = 50%, NT‐pro‐BNP, hsCRP = 40%; PAET and HR = 25% identified pts with cardiovascular risk reduction.2) I and D use associated with almost similar significant reduction of morbidity and mortality. 3) Prognostic Improvement, associated with I use, was due to significant decrease of HR and NT‐pro‐BNP level, and RV functional parameters improvement while D treatment resulted to HR reduction, improvement of LA and RA functional, LV diastolic parameters, neurohormonal and inflammation status"
Notes Funding for trial: No information
Notable conflicts of interest of authors: No information
Contact to authors/unpublished data: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to base judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to base judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding impossible due to comparison with SC.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to base judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to base judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to base judgement
Other bias Unclear risk Insufficient information to base judgement

Abbreviations: ACE = Angiotensin‐converting enzyme, AT1 = angiotensin II type 1, ARB = angiotensin receptor blockers, BB = beta‐blockers, BID = twice daily, BNP = brain natriuretic peptide, BP = blood pressure, bpm = beats per minute, CHF = chronic heart failure, DBP = diastolic blood pressure, 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/Em = the ratio of E and the velocity of the mitral annulus early diastolic wave, ECG = electrocardiogram, EF = ejection fraction, HF = heart failure, HFmrEF = heart failure with mid‐range ejection fraction, HFnEF = heart failure with normal ejection fraction, HFpEF = heart failure with preserved ejection fraction, HFrEF = heart failure with reduced ejection fraction, HR = heart rate, HRV = Heart rate variability, IP = interventional product, KCCQ = Kansas City Cardiomyopathy Questionnaire, LA = left atrial, LV = left ventricular, LVEDV = LV end‐diastolic volume, LVEF = Left ventricular ejection fraction, LVESV = LV end‐systolic volume, max. = maximum, MET = Muscle Energy Technique (physical therapy), MI = myocardial infarction, MPI = Myocardial Performance Index, N = number of participants, NT‐pro‐BNP = N‐terminal pro brain natriuretic peptide, NYHA = New York Heart Association, PEF = preserved ejection fraction, pts = patients, PV = pulmonary vein, pVO2 = peak oxygen uptake, Qol = quality of life, QT interval = time of ventricular activity including both depolarisation and repolarisation, RA = right atrial, RCT = randomised controlled trial, RR‐ interval = beat‐to‐beat interval, RV = right ventricular, SBP = systolic blood pressure, SC = standard care, SD = standard deviation