Phase 3
N=133
PUFAs and Left Ventricular Function in Heart Failure
Dilated Cardiomyopathy · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01223703 ↗Enrolled (actual)
133
Serious AEs
—
Results posted
Jul 2011
Primary outcome: Primary: Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up — 36; 37; 39; 35 ejection fraction (percentage) — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- n-3 PUFAs (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Università degli Studi di Brescia
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up |
36; 37; 39; 35 | < 0.05 sig |
| SECONDARY LV Diastolic Function |
0.89; 0.90; 0.84; 0.98 | < 0.05 sig |
| SECONDARY Functional Capacity (Change in Peak Oxygen Uptake, VO2) |
19.5; 18.3; 20.7; 17.4 | — |
| SECONDARY Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up. |
2.21; 2.17; 1.91; 2.32 | — |
Summary
The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular systolic function in patients with stable chronic HF secondary to nonischemic dilated cardiomyopathy (NICM).
Eligibility Criteria
Inclusion Criteria
- patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary artery disease,defined as the absence of stenosis > 50%, was confirmed by angiography performed at the time of the diagnostic workup of the cardiomyopathy)
- LV systolic dysfunction (defined as an EF < 45%)
- Stable clinical conditions with minimal or no symptoms for at least three month
- Evidence-based medical treatment at maximum tolerated target doses for at least six month
Exclusion Criteria
- presence of symptoms or evidence of CAD diagnosed through noninvasive tests;
- peripheral arterial disease;
- presence of congenital or primary valvular heart disease;
- persistent atrial fibrillation;
- inability to perform bicycle ergometry for noncardiac causes;
- moderately to severely reduced functional capacity;
- NYHA functional class IV;
- poor acoustic windows limiting the ability to assess echocardiographic measurements;
- chronic lung disease;
- advanced renal disease (eGFR < 30 mL/min/1.73 m2);
- advanced liver disease;
- any disease limiting life expectancy to one year or less;
- contraindications to study drugs;
- concomitant participation in other research studies
Data sourced from ClinicalTrials.gov (NCT01223703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.