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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Savina Nodari, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01223703
First received: October 18, 2010
Last updated: January 27, 2012
Last verified: January 2012
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Dilated Cardiomyopathy
Heart Failure
Interventions: Drug: n-3 PUFAs
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    n-3 PUFAs     Placebo  
STARTED     67     66  
COMPLETED     67     66  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    n-3 PUFAs     Placebo     Total  
Number of Participants  
[units: participants]
  67     66     133  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 11     64  ± 9     62.9  ± 10.1  
Gender  
[units: patients]
     
Female     3     10     13  
Male     64     56     120  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   LV Diastolic Function   [ Time Frame: one year ]

3.  Secondary:   Functional Capacity (Change in Peak Oxygen Uptake, VO2)   [ Time Frame: one year ]

4.  Secondary:   Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our investigation was a single-center trial with a small sample size and a limited number of clinical events. Therefore, our results cannot be generalized to HF patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Savina Nodari
Organization: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
phone: 00390303996 ext 587
e-mail: nodari@med.unibs.it


No publications provided


Responsible Party: Savina Nodari, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01223703     History of Changes
Other Study ID Numbers: CS-PUFA-02
Study First Received: October 18, 2010
Results First Received: April 11, 2011
Last Updated: January 27, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health