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Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function (DIGvsIVA)

This study has been completed.
Sponsor:
Collaborator:
Cardiology Office Rheinfelden
Information provided by (Responsible Party):
Cocco G., M.D., Cocco, Giuseppe, M.D.
ClinicalTrials.gov Identifier:
NCT01796093
First received: September 5, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Cardiac Failure With Sinus Rhythm or Atrial Fibrillation.
 Drug: Digoxin and ivabradine
 Phase 4

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.

Resource links provided by NLM:

Drug Information available for: Digoxin
U.S. FDA Resources

Further study details as provided by Cocco, Giuseppe, M.D.:

Primary Outcome Measures:
  • Cardiac function (diastolic and systolic function) [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]
    Cardiac function (echocardiography): systolic function (i.e. LVEF) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave.


Secondary Outcome Measures:
  • Heart rate and blood pressure. [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]
    Changes in heart rate and blood pressure.

  • Dyspnea. [ Time Frame: After 12-14.weeks ] [ Designated as safety issue: No ]
    Changes in dyspnea NYHA class).

  • NB-proBNP value [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]
    Changes (serum values) after therapy.

  • Body weight [ Time Frame: 12-14. weeks ] [ Designated as safety issue: No ]
    Changes after therapy

  • Left atrial size [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]
    Change (size).

  • ECG [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]
    Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias

  • Laboratory [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]
    Any changes in hematology, electrolytes, renal and hepatic function.

  • Side-effects [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]
    Any side-effects, spontaneously reported or after specific questionining.

  • 6-min walk test [ Time Frame: After 12-14 weeks. ] [ Designated as safety issue: No ]
    Changes in length of the walk test and heart rate during the test.


Enrollment: 42
Study Start Date: April 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Digoxin cross-over ivabradine
Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months.
 Drug: Digoxin and ivabradine
No more details
Other Names:
  • Medical therapy in heart failure with atrial fibrillation.
  • Drugs used: digoxin and ivabradine.

Detailed Description:

Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation & stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF.

1 Inclusion criteria:

Dyspnea class III NYHA.

Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).

Patients either in sinus rhythm or with permanent atrial fibrillation.

2. 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 echocardiography.

  Eligibility

Ages Eligible for Study:   60 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with ischemic heart disease and heart failure with preserved systolic function, dyspnea grade III NYHA. Either in sinus rhythm (and possible paroxismal atrial fibrillation) or with permanent atrial fibrillation.

Criteria

Inclusion Criteria:

No need to change concomitant pharmacological therapy in the following months, dyspnea class III NYHA, and abnormal left ventricular relaxation with preserved (≥52%) left ventricular ejection fraction (LVEF).

Exclusion Criteria:

Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796093

Locations
Switzerland
Cardiology office
Rheinfelden, Argovia, Switzerland, CH-4310
Sponsors and Collaborators
Cocco, Giuseppe, M.D.
Cardiology Office Rheinfelden
Investigators
Principal Investigator: Giuseppe Cocco, MD Cardiologist, senior lecturer
  More Information

No publications provided

Responsible Party: Cocco G., M.D., M.D., FESC, Cocco, Giuseppe, M.D.
ClinicalTrials.gov Identifier: NCT01796093     History of Changes
Other Study ID Numbers: GC&PJ-Dig-Iva-2009-2012, Cocco G, M.D.
Study First Received: September 5, 2012
Last Updated: February 19, 2013
Health Authority: Switzerland: Laws and standards

Keywords provided by Cocco, Giuseppe, M.D.:
Digoxin
Ivabradine
Cardiac failure
Economics

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Digoxin
Cardiotonic Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013