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
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy Heart Failure||Drug: n-3 PUFAs Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|Active Comparator: n-3 PUFAs||
Drug: n-3 PUFAs
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.
Other Name: OMACOR, Pronova Biopharma, Lysaker, Norway
|Placebo Comparator: Placebo||
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
- Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up [ Time Frame: one year ]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
- LV Diastolic Function [ Time Frame: one year ]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.
- Functional Capacity (Change in Peak Oxygen Uptake, VO2) [ Time Frame: one year ]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.
- Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up. [ Time Frame: one year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223703
|Arrhytmias and Heart failure Unit-Spedali Civili Hospital|
|Brescia, Italy, 25100|
|Principal Investigator:||Savina Nodari, MD||Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases|
|Study Director:||Livio Dei Cas, MD||Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases|