Clinical trial NCT01796093: Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Official title: Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Atrial Fibrillation
Keywords: Digoxin
Ivabradine
Cardiac failure
Economics
Lead sponsor: Cocco, Giuseppe, M.D.
Sponsor class: INDIV
Collaborators: name: Cardiology Office, Rheinfelden, Switzerland
First posted: 2013-02-21
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief 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

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 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.

Primary outcomes:
measure: Cardiac function (diastolic and systolic function)
timeFrame: After 12-14 weeks
Secondary outcomes:
measure: Heart rate and blood pressure.
timeFrame: After 12-14 weeks
measure: Dyspnea.
timeFrame: After 12-14.weeks
measure: NB-proBNP value
timeFrame: After 12-14 weeks
measure: Body weight
timeFrame: 12-14. weeks
measure: Left atrial size
timeFrame: After 12-14 weeks
measure: ECG
timeFrame: After 12-14 weeks
measure: Laboratory
timeFrame: After 12-14 weeks
measure: Side-effects
timeFrame: After 12-14 weeks
measure: 6-min walk test
timeFrame: After 12-14 weeks.
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Cardiology office
state: Argovia
Study officials:
affiliation: Cardiologist, senior lecturer
name: Giuseppe Cocco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cocco G, Jerie P. Comparison of digoxin and ivabradine in heart failure with preserved systolic function. Submitted to the American Heart Journal.