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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

September 5, 2012
February 19, 2013
April 2008
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01796093 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.

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

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.

Observational [Patient Registry]
Observational Model: Case-Crossover
Time Perspective: Prospective
4 Months
Not Provided
Probability Sample

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.

Cardiac Failure With Sinus Rhythm or Atrial Fibrillation.
Drug: Digoxin and ivabradine
No more details
Other Names:
  • Medical therapy in heart failure with atrial fibrillation.
  • Drugs used: digoxin and ivabradine.
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.
Intervention: Drug: Digoxin and ivabradine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2012
February 2012   (final data collection date for primary outcome measure)

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.

Both
60 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01796093
GC&PJ-Dig-Iva-2009-2012, Cocco G, M.D.
Yes
Cocco G., M.D., Cocco, Giuseppe, M.D.
Cocco, Giuseppe, M.D.
Cardiology Office Rheinfelden
Principal Investigator: Giuseppe Cocco, MD Cardiologist, senior lecturer
Cocco, Giuseppe, M.D.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP