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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00325910
Recruitment Status : Terminated (Insufficient study participants)
First Posted : May 15, 2006
Last Update Posted : May 14, 2008
Information provided by:
University of Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Heart Failure, Congestive Drug: Metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325910

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Canada, Alberta
Misericordia Hospital
Edmonton, Alberta, Canada, T5R 4H5
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Jeffrey A Johnson, PhD University Of Alberta, Alberta, Canada
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00325910    
Other Study ID Numbers: Approval J-2865
Ethics 6002
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008
Keywords provided by University of Alberta:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs