Cardiac FailurePhase 4Dig&IvaNCT01699776
Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure
A Phase 4 study testing Ivabradine and Digoxin in people with Cardiac Failure, run by Cocco, Giuseppe, M.D. at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 78 years
- Conditions the study is for
- Cardiac Failure
- What is being tested?
- Ivabradine and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiology office
Rheinfelden, Canton of Aargau, CH-4310
About this study
Official title: Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function. Time to Rethink About Digoxin.
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).
Read the detailed description
Protocol This is an investigator-started study, coded GC\&PJ-dig-Iva 2009-2012. The study was planned according to the Good Clinical Quality standards and the analysis was performed using an intention-to-treat method. The protocol was approved from an Ethics Committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the data and analysis. Collected data were analyzed from single-blinded investigators (without knowledge of the used test drug and time of collection).
Patients Study design: same patients were assigned to DIG or IVA for 3 months, according to a randomization cross-over design.
Tested drugs Commercial brands of digoxin and ivabradine were used. Digoxin was given by mouth at a dose of 0.125 mg/day, 5 times per week, for 3 months.
Ivabradine was given by mouth at a dose of 7.5 mg bid for 3 months.
Inclusion criteria Chronic and stable coronary artery disease Permanent atrial fibrillation. Diastolic dysfunction with maintained systolic function.
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 echocardiographic quality.
Collected data Medical history and concomitant medications. Physical examination was performed. Laboratory values (including proBNP and serum digoxin concentration). ECG. Echocardiography. 6-minute walk test.
Statistical Analyses Data are expressed as mean ± 1 SD. Absolute values and percent changes in relation to baseline measurements were analyzed. The 2 hypotheses tested were: null hypothesis: mu1-mu2=0.0, and alternative hypothesis: mu1-mu2>>0.0. Comparisons within groups were made using paired t tests or the non-parametric Wilcoxon signed-rank test, where appropriate. Between-group comparisons were performed by unpaired t tests or the non-parametric Mann-Whitney U test, respectively. Chi-square test or Kruskal-Wallis test were used to compare continuous normally or not normally distributed and qualitative variables, where appropriate. Multivariate analysis of variance was performed. A p value of < 0.05 was considered statistically significant.
- Conditions
- Cardiac Failure
- Being tested
- Ivabradine, Digoxin
- Keywords
- Digoxin, Ivabradine, with atrial fibrillation.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Procoralan
7.5 my b.id. by mouth for 12-14 weeks
DigoxinDrug
1.25 mg once a day by mouth, for 12-14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Ivabradine, 7,5 mg b.id. by mouth for 14-16 weeks. Receives: Drug: Ivabradine |
| Digoxin | Active comparator | Digoxin 0.125 mg once a day, 5 times per week, for 12-14 weeks by mouth. Receives: Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative therapeutic effect.
Effects on symptoms and signs of cardiac failure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startApr 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cocco, Giuseppe, M.D.
- Collaborators
- Cardiology Office, Rheinfelden, Switzerland
- Responsible party
- Principal investigator, Cocco G., M.D., Cocco, Giuseppe, M.D.
- Investigators
- Giuseppe Cocco, MD, Principal investigator, Cardiologist, senior lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699776
- Sponsor's protocol ID
- CG&PJ-Dig-Iva 2009-2012
- Acronym
- Dig&Iva
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2012
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24765517
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function. Time to Rethink About Digoxin.
- ClinicalTrials.gov ID
- NCT01699776
- Acronym / sponsor ID
- Dig&Iva / CG&PJ-Dig-Iva 2009-2012
- Conditions
- Cardiac Failure
- Keywords
- Digoxin, Ivabradine, with atrial fibrillation.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cocco, Giuseppe, M.D.
- Collaborators
- Cardiology Office, Rheinfelden, Switzerland
- Study start
- Apr 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Protocol This is an investigator-started study, coded GC\&PJ-dig-Iva 2009-2012. The study was planned according to the Good Clinical Quality standards and the analysis was performed using an intention-to-treat method. The protocol was approved from an Ethics Committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the data and analysis. Collected data were analyzed from single-blinded investigators (without knowledge of the used test drug and time of collection).
Patients Study design: same patients were assigned to DIG or IVA for 3 months, according to a randomization cross-over design.
Tested drugs Commercial brands of digoxin and ivabradine were used. Digoxin was given by mouth at a dose of 0.125 mg/day, 5 times per week, for 3 months.
Ivabradine was given by mouth at a dose of 7.5 mg bid for 3 months.
Inclusion criteria Chronic and stable coronary artery disease Permanent atrial fibrillation. Diastolic dysfunction with maintained systolic function.
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 echocardiographic quality.
Collected data Medical history and concomitant medications. Physical examination was performed. Laboratory values (including proBNP and serum digoxin concentration). ECG. Echocardiography. 6-minute walk test.
Statistical Analyses Data are expressed as mean ± 1 SD. Absolute values and percent changes in relation to baseline measurements were analyzed. The 2 hypotheses tested were: null hypothesis: mu1-mu2=0.0, and alternative hypothesis: mu1-mu2>>0.0. Comparisons within groups were made using paired t tests or the non-parametric Wilcoxon signed-rank test, where appropriate. Between-group comparisons were performed by unpaired t tests or the non-parametric Mann-Whitney U test, respectively. Chi-square test or Kruskal-Wallis test were used to compare continuous normally or not normally distributed and qualitative variables, where appropriate. Multivariate analysis of variance was performed. A p value of < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: IvabradineIvabradine, 7,5 mg b.id. by mouth for 14-16 weeks. |
| Digoxin | Active comparator | Drug: DigoxinDigoxin 0.125 mg once a day, 5 times per week, for 12-14 weeks by mouth. |
Who may qualify
- Ages
- 60 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineAlso: Procoralan7.5 my b.id. by mouth for 12-14 weeks | Drug | Ivabradine |
| Digoxin1.25 mg once a day by mouth, for 12-14 weeks. | Drug | Digoxin |
Primary outcome
Comparative therapeutic effect.
Time frame: 6 months
Effects on symptoms and signs of cardiac failure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Results publication: PubMed 24765517Cocco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Cocco, MD principal investigator
Cardiologist, senior lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine and Digoxin in people with Cardiac Failure, run by Cocco, Giuseppe, M.D. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative therapeutic effect. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.