Cardiac Failure Clinical Trial
— Dig&IvaOfficial title:
Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function. Time to Rethink About Digoxin.
Verified date | October 2012 |
Source | Cocco, Giuseppe, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Laws and standards |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 78 Years |
Eligibility |
Inclusion Criteria: All patients had heart failure NYHA (New York Heart Association) class III. All had chronic and stable coronary artery disease which had been treated with percutaneous dilatation and stenting, and/or aortocoronary bypass. The pathology had induced a permanent AF and heart failure with left ventricular diastolic dysfunction and preserved systolic function. Preserved systolic function was defined by a LVEF (left ventricular ejection fraction) =52%. Left ventricular diastolic dysfunction was defined by a e/e1 ratio > 15 (septal spectral tissue-Doppler). 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Cardiology office | Rheinfelden | Argovia |
Lead Sponsor | Collaborator |
---|---|
Cocco, Giuseppe, M.D. | Cardiology Office, Rheinfelden, Switzerland |
Switzerland,
Cocco G, Jerie P. Comparison between ivabradine and low-dose digoxin in the therapy of diastolic heart failure with preserved left ventricular systolic function. Clin Pract. 2013 Nov 4;3(2):e29. doi: 10.4081/cp.2013.e29. eCollection 2013 Aug 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparative therapeutic effect. | Effects on symptoms and signs of cardiac failure. | 6 months | Yes |
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