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Trial record 58 of 157 for:    Idiopathic Dilated Cardiomyopathy

PUFAs and Left Ventricular Function in Heart Failure (CS-PUFA-02)

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ClinicalTrials.gov Identifier: NCT01223703
Recruitment Status : Completed
First Posted : October 19, 2010
Results First Posted : July 25, 2011
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Savina Nodari, Università degli Studi di Brescia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Dilated Cardiomyopathy
Heart Failure
Interventions Drug: n-3 PUFAs
Drug: Placebo
Enrollment 133
Recruitment Details Potential participants were recruited consecutively from the Heart Failure (HF) outpatient clinic of the University of Brescia. The first patient was enrolled on November 5, 2007, and the last patient completed the study on June 30, 2009.
Pre-assignment Details 458 patients were assessed for eligibility. 235 patients were excluded: 251 not meeting inclusion criteria; 74 refused to participate. A total of 133 patients took part in the study.
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description 1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study. 1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Period Title: Overall Study
Started 67 66
Completed 67 66
Not Completed 0 0
Arm/Group Title n-3 PUFAs Placebo Total
Hide Arm/Group Description 1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study. 1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study Total of all reporting groups
Overall Number of Baseline Participants 67 66 133
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 66 participants 133 participants
61  (11) 64  (9) 62.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 66 participants 133 participants
Female
3
   4.5%
10
  15.2%
13
   9.8%
Male
64
  95.5%
56
  84.8%
120
  90.2%
1.Primary Outcome
Title Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up
Hide Description The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
A sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with p<0.05 (2-tailed) at the Student t test for unpaired data.
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description:
1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Overall Number of Participants Analyzed 67 66
Mean (Standard Deviation)
Unit of Measure: ejection fraction (percentage)
baseline 36  (7) 37  (6)
12th month follow up 39  (6) 35  (6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection n-3 PUFAs, Placebo
Comments

null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.

for unpaired data.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.
2.Secondary Outcome
Title LV Diastolic Function
Hide Description Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description:
1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Overall Number of Participants Analyzed 67 66
Mean (Standard Deviation)
Unit of Measure: E/A ratio
E/A baseline 0.89  (0.29) 0.90  (0.37)
E/A 12 month 0.84  (0.19) 0.98  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection n-3 PUFAs, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.
3.Secondary Outcome
Title Functional Capacity (Change in Peak Oxygen Uptake, VO2)
Hide Description Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description:
1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Overall Number of Participants Analyzed 67 66
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
baseline 19.5  (3.8) 18.3  (4.4)
12th month 20.7  (4.3) 17.4  (4.2)
4.Secondary Outcome
Title Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.
Hide Description

NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...

NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description:
1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Overall Number of Participants Analyzed 67 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 2.21  (0.51) 2.17  (0.57)
12th month 1.91  (0.54) 2.32  (0.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title n-3 PUFAs Placebo
Hide Arm/Group Description 1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study. 1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
All-Cause Mortality
n-3 PUFAs Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
n-3 PUFAs Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
n-3 PUFAs Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/66 (0.00%) 
Our investigation was a single-center trial with a small sample size and a limited number of clinical events. Therefore, our results cannot be generalized to HF patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Savina Nodari
Organization: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Phone: 00390303996 ext 587
EMail: nodari@med.unibs.it
Publications:
1.Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet2008;372:1223-30. 2.Duda MK, O'Shea KM, Tintinu A, et al. Fish oil, but not flaxseed oil, decreases inflammation and prevents pressure overload-induced cardiac dysfunction. Cardiovasc Res 2009;81:319-27. 3.Duda MK, O'Shea KM, Lei B, et al. Dietary supplementation with omega-3 PUFA increases adiponectin and attenuates ventricular remodeling and dysfunction with pressure overload. Cardiovasc Res 2007;76:303-10. 4.Vargiu R, Littarru GP, Fraschini M, et al. Enhancement of shortening velocity, power, and acto-myosin crossbridge (CB) kinetics following long-term treatment with propionyl-L-carnitine, coenzyme Q10, and omega-3 fatty acids in BIO TO-2 cardiomyopathic Syrian hamsters papillary muscle. Biofactors 2010;36:229-39. 5.Pepe S, McLennan PL. Cardiac membrane fatty acid composition modulates myocardial oxygen consumption and postischemic recovery of contractile function. Circulation 2002;105:2303-8. 6.Duda MK, O'Shea KM, Stanley WC. omega-3 polyunsaturated fatty acid supplementation for the treatment of heart failure: mechanisms and clinical potential. Cardiovasc Res 2009;84:33-41.
Layout table for additonal information
Responsible Party: Savina Nodari, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01223703     History of Changes
Other Study ID Numbers: CS-PUFA-02
First Submitted: October 18, 2010
First Posted: October 19, 2010
Results First Submitted: April 11, 2011
Results First Posted: July 25, 2011
Last Update Posted: January 31, 2012