Trial Outcomes & Findings for Heart Rate Reduction in Heart Failure (NCT NCT01178528)

NCT ID: NCT01178528

Last Updated: 2014-09-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 121 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2014-09-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	41	38	42
Overall Study COMPLETED	41	38	42
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Rate Reduction in Heart Failure

Baseline characteristics by cohort

Measure	Ivabradine n=41 Participants up to 7.5 mg b.i.d.	Carvedilol n=38 Participants up to 25 mg b.i.d.	Carvedilol and Ivabradine n=42 Participants up to 12.5 / 5 mg b.i.d.	Total n=121 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	29 Participants n=7 Participants	32 Participants n=5 Participants	91 Participants n=4 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Sex/Gender, Customized MALE	28 participants n=5 Participants	26 participants n=7 Participants	28 participants n=5 Participants	82 participants n=4 Participants
Sex/Gender, Customized FEMALE	13 participants n=5 Participants	12 participants n=7 Participants	14 participants n=5 Participants	39 participants n=4 Participants
Region of Enrollment Italy	41 participants n=5 Participants	38 participants n=7 Participants	42 participants n=5 Participants	121 participants n=4 Participants
Exercise Tolerance Assessed by 6 Minute Walking Test	346.7 meters STANDARD_DEVIATION 112.0 • n=5 Participants	379.0 meters STANDARD_DEVIATION 96.3 • n=7 Participants	358.2 meters STANDARD_DEVIATION 107.6 • n=5 Participants	361.3 meters STANDARD_DEVIATION 105.3 • n=4 Participants
Maximal Oxygen Consumption	12.05 mL/Kg/min STANDARD_DEVIATION 2.1 • n=5 Participants	12.3 mL/Kg/min STANDARD_DEVIATION 2.6 • n=7 Participants	12.4 mL/Kg/min STANDARD_DEVIATION 2.5 • n=5 Participants	12.25 mL/Kg/min STANDARD_DEVIATION 2.4 • n=4 Participants
Quality of Life	4.3 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	4.6 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	4.7 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	4.5 units on a scale STANDARD_DEVIATION 0.7 • n=4 Participants
New York Heart Association (NYHA) class class II	20 participants n=5 Participants	22 participants n=7 Participants	21 participants n=5 Participants	63 participants n=4 Participants
New York Heart Association (NYHA) class class III	21 participants n=5 Participants	16 participants n=7 Participants	21 participants n=5 Participants	58 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ivabradine n=41 Participants up to 7.5 mg b.i.d.	Carvedilol n=38 Participants up to 25 mg b.i.d.	Carvedilol and Ivabradine n=42 Participants up to 12.5 / 5 mg b.i.d.
Exercise Tolerance Assessed by 6 Minute Walking Test	474.8 meters Standard Deviation 127.3	435.7 meters Standard Deviation 121.3	453.1 meters Standard Deviation 87.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ivabradine n=41 Participants up to 7.5 mg b.i.d.	Carvedilol n=38 Participants up to 25 mg b.i.d.	Carvedilol and Ivabradine n=42 Participants up to 12.5 / 5 mg b.i.d.
Maximal Oxygen Consumption	15.8 mL/Kg/min Standard Deviation 1.9	12.9 mL/Kg/min Standard Deviation 2.4	14.7 mL/Kg/min Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ivabradine n=41 Participants up to 7.5 mg b.i.d.	Carvedilol n=38 Participants up to 25 mg b.i.d.	Carvedilol and Ivabradine n=42 Participants up to 12.5 / 5 mg b.i.d.
Quality of Life	6.7 units on a scale Standard Deviation 0.9	4.1 units on a scale Standard Deviation 0.6	6.1 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ivabradine n=41 Participants up to 7.5 mg b.i.d.	Carvedilol n=38 Participants up to 25 mg b.i.d.	Carvedilol and Ivabradine n=42 Participants up to 12.5 / 5 mg b.i.d.
New York Heart Association (NYHA) Class	30 participants	5 participants	20 participants

Adverse Events

Ivabradine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carvedilol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carvedilol and Ivabradine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

G Rosano

IRCCS San Raffaele

Phone: 0652252309

Email: giuseppe.rosano@sanraffaele.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place