Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure
Condition: Cardiac Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in
      patients with heart failure, especially in the presence of atrial fibrillation (AF). It is
      the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical
      outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart
      failure was compared.

      Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with
      preserved left ventricular systolic function were treated with digoxin and ivabradine for 3
      months, according to a randomization cross-over design.

      Collected data Medical history, physical examination, laboratory (including proBNP and serum
      digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi,
      e/e1 ratio).
    

Detailed description: 
      Protocol This is an investigator-started study, coded GC&PJ-dig-Iva 2009-2012. The study was
      planned according to the Good Clinical Quality standards and the analysis was performed using
      an intention-to-treat method. The protocol was approved from an Ethics Committee. Selected
      patients gave their written informed consent. The family practitioners agreed and obtained
      the data and analysis. Collected data were analyzed from single-blinded investigators
      (without knowledge of the used test drug and time of collection).

      Patients Study design: same patients were assigned to DIG or IVA for 3 months, according to a
      randomization cross-over design.

      Tested drugs Commercial brands of digoxin and ivabradine were used. Digoxin was given by
      mouth at a dose of 0.125 mg/day, 5 times per week, for 3 months.

      Ivabradine was given by mouth at a dose of 7.5 mg bid for 3 months.

      Inclusion criteria Chronic and stable coronary artery disease Permanent atrial fibrillation.
      Diastolic dysfunction with maintained systolic function.

      Exclusion criteria Unstable angina pectoris. Reduced systolic cardiac function (LVEF<52%).
      Normal diastolic function. Diabetes requiring insulin. Moderate or severe renal or hepatic
      dysfunction. Technically insufficient echocardiographic quality.

      Collected data Medical history and concomitant medications. Physical examination was
      performed. Laboratory values (including proBNP and serum digoxin concentration). ECG.
      Echocardiography. 6-minute walk test.

      Statistical Analyses Data are expressed as mean ± 1 SD. Absolute values and percent changes
      in relation to baseline measurements were analyzed. The 2 hypotheses tested were: null
      hypothesis: mu1-mu2=0.0, and alternative hypothesis: mu1-mu2>>0.0. Comparisons within groups
      were made using paired t tests or the non-parametric Wilcoxon signed-rank test, where
      appropriate. Between-group comparisons were performed by unpaired t tests or the
      non-parametric Mann-Whitney U test, respectively. Chi-square test or Kruskal-Wallis test were
      used to compare continuous normally or not normally distributed and qualitative variables,
      where appropriate. Multivariate analysis of variance was performed. A p value of < 0.05 was
      considered statistically significant.
    

Intervention name(s): Ivabradine; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): 7.5 my b.id. by mouth for 12-14 weeks; 1.25 mg once a day by mouth, for 12-14 weeks.
Other intervention name(s): Procoralan
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Digoxin; Ivabradine; with atrial fibrillation.