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