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Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.
Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes > 3 months Revascularization procedures > 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months
Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.
Efficacy measure Intention to treat Exercise tolerance Quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental | 7.5 mg bd |
|
| Carvedilol | Active Comparator | up to 25 mg bd |
|
| "Drug:Carvedilol" and "Drug:Ivabradine" | Experimental | up to 12.5/5 mg bd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivabradine | Drug | 7.5 mg bd |
| |
| "Drug:Carvedilol" and "Drug:Ivabradine" |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Tolerance Assessed by 6 Minute Walking Test | Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist. Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible. | 3 months |
| Maximal Oxygen Consumption | Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Volterrani, MD | IRCCS San Raffaele | Principal Investigator |
| Giuseppe MC Rosano, MD, PhD | IRCCS San Raffaele | Study Chair |
| Cristiana Vitale, MD, PhD | IRCCS San Raffaele | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical and Basic Research - IRCCS San Raffaele | Roma | Italy | 00100 | Italy | ||
| IRCCS San Raffaele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19944362 | Background | Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3. | |
| 19892778 |
| Label | URL |
|---|---|
| European Society Cardiology guidelines | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivabradine | up to 7.5 mg b.i.d. |
| FG001 | Carvedilol | up to 25 mg b.i.d. |
| FG002 | Carvedilol and Ivabradine | up to 12.5 / 5 mg b.i.d. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ivabradine | up to 7.5 mg b.i.d. |
| BG001 | Carvedilol | up to 25 mg b.i.d. |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Tolerance Assessed by 6 Minute Walking Test | Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist. Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible. | Mean | Standard Deviation | meters | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivabradine | up to 7.5 mg b.i.d. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G Rosano | IRCCS San Raffaele | 0652252309 | giuseppe.rosano@sanraffaele.it |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
up to 12.5/5 mg bd |
|
| Carvedilol | Drug | 25 mg bd |
|
| New York Heart Association (NYHA) Class | The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient's limitations in physical activities caused by cardiac symptoms. Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD. Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD. Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD. Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD. Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation. | 3 months |
| Roma |
| Italy |
| 00100 |
| Italy |
| Background |
| Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L. Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial (SHIFT). Eur J Heart Fail. 2010 Jan;12(1):75-81. doi: 10.1093/eurjhf/hfp154. Epub 2009 Nov 5. |
| Carvedilol and Ivabradine |
up to 12.5 / 5 mg b.i.d. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Exercise Tolerance Assessed by 6 Minute Walking Test | Mean | Standard Deviation | meters |
|
| Maximal Oxygen Consumption | Mean | Standard Deviation | mL/Kg/min |
|
| Quality of Life | Mean | Standard Deviation | units on a scale |
|
| New York Heart Association (NYHA) class | The NYHA Classification system is a measure of functional status. Class II describes patients with cardiovascular disease (CVD) resulting in slight limitation of physical activity and comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. There is objective evidence of minimal CVD. Class III describes patients with CVD resulting in marked limitation of physical activity and comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. There is objective evidence of moderately severe CVD. | Number | participants |
|
| OG001 | Carvedilol | up to 25 mg b.i.d. |
| OG002 | Carvedilol and Ivabradine | up to 12.5 / 5 mg b.i.d. |
|
|
| Secondary | Quality of Life | Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome. | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Primary | Maximal Oxygen Consumption | Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise. | Mean | Standard Deviation | mL/Kg/min | 3 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Class | The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient's limitations in physical activities caused by cardiac symptoms. Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD. Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD. Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD. Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD. Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation. | Number | participants | 3 months |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Carvedilol | up to 25 mg b.i.d. | 0 | 38 | 0 | 38 |
| EG002 | Carvedilol and Ivabradine | up to 12.5 / 5 mg b.i.d. | 0 | 42 | 0 | 42 |
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| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |