Trial · NCT01178528
Heart Rate Reduction in Heart Failure
NCT01178528, Phase 3, Completed, IRCCS San Raffaele; results first posted 2014-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Heart Rate Reduction in Heart Failure. Trials, record NCT01178528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01178528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Heart Rate Reduction in Heart Failure
- NCT number
- NCT01178528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 121 participants, actual
- Lead sponsor
- IRCCS San Raffaele
- Conditions
- Heart Failure
- Interventions
- ivabradine, "Drug:Carvedilol" and "Drug:Ivabradine", Carvedilol
- First posted
- 2010-08-10
- Last updated
- 2014-09-30
- Results first posted
- 2014-09-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exercise Tolerance Assessed by 6 Minute Walking Test | 3 months | 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. |
| Primary | Maximal Oxygen Consumption | 3 months | 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. |
| Secondary | Quality of Life | 3 months | 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. |
| Secondary | New York Heart Association (NYHA) Class | 3 months | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exercise Tolerance Assessed by 6 Minute Walking Test | 3 months | meters | MEAN | |
| SECONDARY | Quality of Life | 3 months | units on a scale | MEAN | |
| PRIMARY | Maximal Oxygen Consumption | 3 months | mL/Kg/min | MEAN | |
| SECONDARY | New York Heart Association (NYHA) Class | 3 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exercise Tolerance Assessed by 6 Minute Walking Test | Ivabradine | 474.8 | Standard Deviation 127.3 | meters | |
| Exercise Tolerance Assessed by 6 Minute Walking Test | Carvedilol | 435.7 | Standard Deviation 121.3 | meters | |
| Exercise Tolerance Assessed by 6 Minute Walking Test | Carvedilol and Ivabradine | 453.1 | Standard Deviation 87.4 | meters | |
| Quality of Life | Ivabradine | 6.7 | Standard Deviation 0.9 | units on a scale | |
| Quality of Life | Carvedilol | 4.1 | Standard Deviation 0.6 | units on a scale | |
| Quality of Life | Carvedilol and Ivabradine | 6.1 | Standard Deviation 0.6 | units on a scale | |
| Maximal Oxygen Consumption | Ivabradine | 15.8 | Standard Deviation 1.9 | mL/Kg/min | |
| Maximal Oxygen Consumption | Carvedilol | 12.9 | Standard Deviation 2.4 | mL/Kg/min | |
| Maximal Oxygen Consumption | Carvedilol and Ivabradine | 14.7 | Standard Deviation 1.6 | mL/Kg/min | |
| New York Heart Association (NYHA) Class | Ivabradine | 30 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ivabradine | 41 | |
| Overall Study | STARTED | Carvedilol | 38 | |
| Overall Study | STARTED | Carvedilol and Ivabradine | 42 | |
| Overall Study | COMPLETED | Ivabradine | 41 | |
| Overall Study | COMPLETED | Carvedilol | 38 | |
| Overall Study | COMPLETED | Carvedilol and Ivabradine | 42 | |
| Overall Study | NOT COMPLETED | Ivabradine | 0 | |
| Overall Study | NOT COMPLETED | Carvedilol | 0 | |
| Overall Study | NOT COMPLETED | Carvedilol and Ivabradine | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivabradine | ||
| Total, all-cause mortality | Carvedilol | ||
| Total, all-cause mortality | Carvedilol and Ivabradine | ||
| Total, other adverse events | Ivabradine | 0 | 41 |
| Total, other adverse events | Carvedilol | 0 | 38 |
| Total, other adverse events | Carvedilol and Ivabradine | 0 | 42 |
| Total, serious adverse events | Ivabradine | 0 | 41 |
| Total, serious adverse events | Carvedilol | 0 | 38 |
| Total, serious adverse events | Carvedilol and Ivabradine | 0 | 42 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01178528
GET https://conductscience.org/api/trials/v1/NCT01178528/registered