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Trial Outcomes & Findings for PUFAs and Left Ventricular Function in Heart Failure (NCT NCT01223703)

NCT ID: NCT01223703

Last Updated: 2012-01-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

133 participants

Primary outcome timeframe

one year

Results posted on

2012-01-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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
Overall Study
STARTED
67
66
Overall Study
COMPLETED
67
66
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PUFAs and Left Ventricular Function in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
n-3 PUFAs
n=67 Participants
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.
Placebo
n=66 Participants
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
n=133 Participants
Total of all reporting groups
Age Continuous
61 years
STANDARD_DEVIATION 11 • n=93 Participants
64 years
STANDARD_DEVIATION 9 • n=4 Participants
62.9 years
STANDARD_DEVIATION 10.1 • n=27 Participants
Sex: Female, Male
Female
3 Participants
n=93 Participants
10 Participants
n=4 Participants
13 Participants
n=27 Participants
Sex: Female, Male
Male
64 Participants
n=93 Participants
56 Participants
n=4 Participants
120 Participants
n=27 Participants

PRIMARY outcome

Timeframe: one year

Population: 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.

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

Outcome measures

Outcome measures
Measure
n-3 PUFAs
n=67 Participants
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.
Placebo
n=66 Participants
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
baseline
36 ejection fraction (percentage)
Standard Deviation 7
37 ejection fraction (percentage)
Standard Deviation 6
Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up
12th month follow up
39 ejection fraction (percentage)
Standard Deviation 6
35 ejection fraction (percentage)
Standard Deviation 6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
n-3 PUFAs
n=67 Participants
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.
Placebo
n=66 Participants
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
LV Diastolic Function
E/A baseline
0.89 E/A ratio
Standard Deviation 0.29
0.90 E/A ratio
Standard Deviation 0.37
LV Diastolic Function
E/A 12 month
0.84 E/A ratio
Standard Deviation 0.19
0.98 E/A ratio
Standard Deviation 0.40

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
n-3 PUFAs
n=67 Participants
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.
Placebo
n=66 Participants
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
Functional Capacity (Change in Peak Oxygen Uptake, VO2)
baseline
19.5 ml/kg/min
Standard Deviation 3.8
18.3 ml/kg/min
Standard Deviation 4.4
Functional Capacity (Change in Peak Oxygen Uptake, VO2)
12th month
20.7 ml/kg/min
Standard Deviation 4.3
17.4 ml/kg/min
Standard Deviation 4.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
n-3 PUFAs
n=67 Participants
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.
Placebo
n=66 Participants
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 Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.
baseline
2.21 units on a scale
Standard Deviation 0.51
2.17 units on a scale
Standard Deviation 0.57
Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.
12th month
1.91 units on a scale
Standard Deviation 0.54
2.32 units on a scale
Standard Deviation 0.61

Adverse Events

n-3 PUFAs

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

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

Dr Savina Nodari

Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

Phone: 00390303996

Results disclosure agreements

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