Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 92 of 116 for:    Atenolol

Heart Rate Reduction in Heart Failure (CARVIVA-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01178528
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Giuseppe M.C. Rosano, IRCCS San Raffaele

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: ivabradine
Drug: "Drug:Carvedilol" and "Drug:Ivabradine"
Drug: Carvedilol
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description up to 7.5 mg b.i.d. up to 25 mg b.i.d. up to 12.5 / 5 mg b.i.d.
Period Title: Overall Study
Started 41 38 42
Completed 41 38 42
Not Completed 0 0 0
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine Total
Hide Arm/Group Description up to 7.5 mg b.i.d. up to 25 mg b.i.d. up to 12.5 / 5 mg b.i.d. Total of all reporting groups
Overall Number of Baseline Participants 41 38 42 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 42 participants 121 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  73.2%
29
  76.3%
32
  76.2%
91
  75.2%
>=65 years
11
  26.8%
9
  23.7%
10
  23.8%
30
  24.8%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 42 participants 121 participants
MALE 28 26 28 82
FEMALE 13 12 14 39
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 41 participants 38 participants 42 participants 121 participants
41 38 42 121
Exercise Tolerance Assessed by 6 Minute Walking Test  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 41 participants 38 participants 42 participants 121 participants
346.7  (112.0) 379.0  (96.3) 358.2  (107.6) 361.3  (105.3)
Maximal Oxygen Consumption  
Mean (Standard Deviation)
Unit of measure:  mL/Kg/min
Number Analyzed 41 participants 38 participants 42 participants 121 participants
12.05  (2.1) 12.3  (2.6) 12.4  (2.5) 12.25  (2.4)
Quality of Life  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 38 participants 42 participants 121 participants
4.3  (0.5) 4.6  (0.8) 4.7  (0.8) 4.5  (0.7)
New York Heart Association (NYHA) class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 42 participants 121 participants
class II 20 22 21 63
class III 21 16 21 58
[1]
Measure Description: 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.
1.Primary Outcome
Title Exercise Tolerance Assessed by 6 Minute Walking Test
Hide Description

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.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description:
up to 7.5 mg b.i.d.
up to 25 mg b.i.d.
up to 12.5 / 5 mg b.i.d.
Overall Number of Participants Analyzed 41 38 42
Mean (Standard Deviation)
Unit of Measure: meters
474.8  (127.3) 435.7  (121.3) 453.1  (87.4)
2.Primary Outcome
Title Maximal Oxygen Consumption
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description:
7.5 mg b.i.d.
up to 25 mg b.i.d.
up to 12.5 / 5 mg b.i.d.
Overall Number of Participants Analyzed 41 38 42
Mean (Standard Deviation)
Unit of Measure: mL/Kg/min
15.8  (1.9) 12.9  (2.4) 14.7  (1.6)
3.Secondary Outcome
Title Quality of Life
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description:
up to 7.5 mg b.i.d.
up to 25 mg b.i.d.
up to 12.5 / 5 mg b.i.d.
Overall Number of Participants Analyzed 41 38 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.7  (0.9) 4.1  (0.6) 6.1  (0.6)
4.Secondary Outcome
Title New York Heart Association (NYHA) Class
Hide Description

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.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description:
up to 7.5 mg b.i.d.
up to 25 mg b.i.d.
up to 12.5 / 5 mg b.i.d.
Overall Number of Participants Analyzed 41 38 42
Measure Type: Number
Unit of Measure: participants
30 5 20
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ivabradine Carvedilol Carvedilol and Ivabradine
Hide Arm/Group Description up to 7.5 mg b.i.d. up to 25 mg b.i.d. up to 12.5 / 5 mg b.i.d.
All-Cause Mortality
Ivabradine Carvedilol Carvedilol and Ivabradine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ivabradine Carvedilol Carvedilol and Ivabradine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ivabradine Carvedilol Carvedilol and Ivabradine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%)   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: G Rosano
Organization: IRCCS San Raffaele
Phone: 0652252309
EMail: giuseppe.rosano@sanraffaele.it
Layout table for additonal information
Responsible Party: Giuseppe M.C. Rosano, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01178528     History of Changes
Other Study ID Numbers: CTG001-07
First Submitted: April 19, 2010
First Posted: August 10, 2010
Results First Submitted: September 19, 2013
Results First Posted: September 30, 2014
Last Update Posted: September 30, 2014