Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

NCT01796093 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2017-02-01

No results posted yet for this study

Summary

This is an investigator-started study. The trial is coded as no. GC\&PJ-Dig-Iva2009-2012.

The authors have no conflict of interest and there was no financial sponsoring The study was planned according to the Good Clinical Quality standards using an intention-to-treat analysis. The protocol was approved from the ethics committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the collected data and analysis. Analysis of collected data was performed by a single-blinded author (without knowledge of the used test drug and time of collection of data).

Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with permanent atrial fibrillation (ischemic etiology).

Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.

Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):

Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection rate, left trial size,diastolic function.

Participants were followed (ambulatory observation) for at least 3 months

Conditions

Interventions

DRUG

Digoxin and ivabradine

No more details

Sponsors & Collaborators

  • Cardiology Office, Rheinfelden, Switzerland

    collaborator OTHER
  • Cocco, Giuseppe, M.D.

    lead INDIV

Principal Investigators

  • Giuseppe Cocco, MD · Cardiologist, senior lecturer

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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Entities

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 NCT01796093 on ClinicalTrials.gov