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Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure

NCT01699776 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-11-11

No results posted yet for this study

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).

Conditions

  • Cardiac Failure

Interventions

DRUG

Ivabradine

7.5 my b.id. by mouth for 12-14 weeks

DRUG

Digoxin

1.25 mg once a day by mouth, for 12-14 weeks.

Sponsors & Collaborators

  • Cardiology Office, Rheinfelden, Switzerland

    collaborator OTHER

  • Cocco, Giuseppe, M.D.

    lead INDIV

Principal Investigators

  • Giuseppe Cocco, MD · Cardiologist, senior lecturer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699776 on ClinicalTrials.gov