Brief Title
PUFAs and Left Ventricular Function in Heart Failure
Official Title
Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy
Brief 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).
Detailed Description
The results of the GISSI-HF trial indicate that in patients with chronic HF on evidence-based
medical therapy and New York Heart Association (NYHA) functional class II-IV, long term
treatment with n-3 PUFAs 1 g daily reduces mortality and hospitalizations for cardiovascular
reasons. Several potential mechanisms may underlie the beneficial effects of n-3
polyunsaturated fatty acids (PUFAs) in HF patients, including, but not limited to,
antiarrhythmic, and hemodynamic actions. The current investigation was therefore designed to
test the hypothesis that treatment with n-3 PUFAs improves LV systolic function expressed as
EF in patients with stable chronic HF secondary to a nonischemic dilated cardiomyopathy
(NICM). Additionally, we sought to determine if n-3 PUFAs also exert positive effects on LV
diastolic function assessed by echocardiography; functional capacity assessed by
cardiopulmonary stress testing (CPET); and New York Heart Association (NYHA) functional
class.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up
Secondary Outcome
LV Diastolic Function
Condition
Dilated Cardiomyopathy
Intervention
n-3 PUFAs
Study Arms / Comparison Groups
n-3 PUFAs
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
133
Start Date
November 2007
Completion Date
June 2009
Primary Completion Date
June 2009
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Savina Nodari, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01223703
Organization ID
CS-PUFA-02
Responsible Party
Principal Investigator
Study Sponsor
Università degli Studi di Brescia
Study Sponsor
Savina Nodari, MD, Principal Investigator, Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Verification Date
January 2012