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Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

This study has been terminated.
( Insufficient study participants )

Sponsored by: University of Alberta
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00325910
  Purpose

To conduct a pilot study to evaluate the feasibility of a large randomized controlled trial (RCT) of metformin in patients with heart failure and type 2 diabetes and to generate initial morbidity and mortality estimates in this patient population. The primary hypothesis is that subjects with heart failure and type 2 diabetes who receive metformin will have a significant reduction in the combined endpoint of all-cause mortality and all-cause hospitalization as compared to subjects who receive placebo therapy.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Heart Failure, Congestive
Drug: Metformin
Phase III

MedlinePlus related topics:   Diabetes    Heart Failure   

ChemIDplus related topics:   Metformin    Metformin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Combined endpoint of all cause mortality and all cause hospitalization at 6 months

Secondary Outcome Measures:
  • Individual components of the primary outcome (ie death or hospitalization)
  • Change in A1c
  • Change in 6 minute walk
  • Change in Health Related Quality of Life
  • Development of Lactic Acidosis

Estimated Enrollment:   100
Study Start Date:   May 2006
Study Completion Date:   May 2007
Primary Completion Date:   May 2007 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • All subjects with physician-diagnosed symptomatic heart failure (NYHA class I, II, III, IV) and type 2 diabetes.

A diagnosis of type 2 diabetes defined as:

  • a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or;
  • receiving oral antihyperglycemic agents or;
  • a new diagnosis of type 2 diabetes during the visit within the heart failure clinic or hospital based on a fasting blood glucose ≥7.0 mmol/L or random blood glucose ≥11.1 mmol/L accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/L.

Exclusion Criteria:

  • subjects currently receiving greater than 1500 mg of metformin therapy per day
  • subjects who are unwilling to change their antidiabetic regimens;
  • subjects receiving insulin therapy;
  • serum creatinine ≥ 180 μmol/L;
  • A1c < 7.0 percent;
  • inability to communicate (language barrier);
  • dementia/mental illness;
  • age < 18 years;
  • subjects unwilling to complete self-monitoring of serum blood sugars during the trial period.
  • those participating in another heart failure or diabetes clinical trial involving medication;
  • severe comorbidities or foreshortened life expectancy;
  • subjects who do not provide written informed consent to participate.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325910

Locations
Canada, Alberta
University of Alberta Hospital    
      Edmonton, Alberta, Canada, T6G 2B7
Misericordia Hospital    
      Edmonton, Alberta, Canada, T5R 4H5

Sponsors and Collaborators
University of Alberta

Investigators
Principal Investigator:     Jeffrey A Johnson, PhD     University Of Alberta, Alberta, Canada    
  More Information

Publications:

Study ID Numbers:   Approval J-2865, Ethics 6002
First Received:   May 12, 2006
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00325910
Health Authority:   Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Diabetes  
Heart Failure  
Mortality  
Hospitalization  
Feasability  

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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