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

This study has been terminated.
(Insufficient study participants)
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00325910
First received: May 12, 2006
Last updated: May 12, 2008
Last verified: May 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

Resource links provided by NLM:


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

  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
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, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325910     History of Changes
Other Study ID Numbers: Approval J-2865, Ethics 6002
Study First Received: May 12, 2006
Last Updated: May 12, 2008
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014