Heart FailureDIGvsIVANCT01796093
Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
An observational study of Heart Failure and Atrial Fibrillation, run by Cocco, Giuseppe, M.D. at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 78 years
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- Digoxin and ivabradine
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Feb 2012
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
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.
Who may be able to join
- 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).
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.
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).
Read more
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
Read the 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.
- 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.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- Digoxin and ivabradine
- Keywords
- Digoxin, Ivabradine, Cardiac failure, Economics
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digoxin and ivabradineDrug
Also called Medical therapy in heart failure with atrial fibrillation., Drugs used: digoxin and ivabradine.
No more details
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Digoxin and ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function (diastolic and systolic function)
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.
Measured: After 12-14 weeks
Secondary outcomes (9)
Heart rate and blood pressure.
Changes in heart rate and blood pressure.
Measured: After 12-14 weeks
Dyspnea.
Changes in dyspnea NYHA class).
Measured: After 12-14.weeks
NB-proBNP value
Changes (serum values) after therapy.
Measured: After 12-14 weeks
Body weight
Changes after therapy
Measured: 12-14. weeks
Left atrial size
Change (size).
Measured: After 12-14 weeks
ECG
Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias
Measured: After 12-14 weeks
Laboratory
Any changes in hematology, electrolytes, renal and hepatic function.
Measured: After 12-14 weeks
Side-effects
Any side-effects, spontaneously reported or after specific questionining.
Measured: After 12-14 weeks
6-min walk test
Changes in length of the walk test and heart rate during the test.
Measured: After 12-14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (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 Heart 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 4 Months
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
- NCT01796093
- Sponsor's protocol ID
- GC&PJ-Dig-Iva-2009-2012
- Other IDs
- Cocco G, M.D.
- Acronym
- DIGvsIVA
- Status last verified
- Jan 2017
- First submitted
- 5 Sep 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cocco G, Jerie P. Comparison of digoxin and ivabradine in heart failure with preserved systolic function. Submitted to the American Heart Journal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. 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.
- ClinicalTrials.gov ID
- NCT01796093
- Acronym / sponsor ID
- DIGvsIVA / GC&PJ-Dig-Iva-2009-2012
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- Digoxin, Ivabradine, Cardiac failure, Economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 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
- 21 Feb 2013 (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.
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.
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digoxin cross-over ivabradine | – | Drug: Digoxin and ivabradineDigoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months. |
Who may qualify
- Ages
- 60 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| Digoxin and ivabradineAlso: Medical therapy in heart failure with atrial fibrillation., Drugs used: digoxin and ivabradine.No more details | Drug | Digoxin cross-over ivabradine |
Primary outcome
Cardiac function (diastolic and systolic function)
Time frame: After 12-14 weeks
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.
9 secondary outcomes
Heart rate and blood pressure.
Time frame: After 12-14 weeks
Dyspnea.
Time frame: After 12-14.weeks
NB-proBNP value
Time frame: After 12-14 weeks
Body weight
Time frame: 12-14. weeks
Left atrial size
Time frame: After 12-14 weeks
ECG
Time frame: After 12-14 weeks
Laboratory
Time frame: After 12-14 weeks
Side-effects
Time frame: After 12-14 weeks
6-min walk test
Time frame: After 12-14 weeks.
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 1 Feb 2017.
- Results publicationCocco G, Jerie P. Comparison of digoxin and ivabradine in heart failure with preserved systolic function. Submitted to the American Heart Journal.
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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?
An observational study of Heart Failure and Atrial Fibrillation, 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 1 Feb 2017. 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.
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?
Cardiac function (diastolic and systolic function) (time frame: After 12-14 weeks). 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 NCT01796093, 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 1 Feb 2017.