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Clinical Trials/NCT02122835
NCT02122835
Withdrawn
Not Applicable

Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes

Duke University1 site in 1 countryFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Duke University
Locations
1
Primary Endpoint
exercise capacity
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

Detailed Description

The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
September 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥50 yr of age
  • New York Heart Association class II-III CHF and ejection fraction ≤35%
  • receiving optimal medical therapy
  • sedentary (≤ 30 min/wk structured physical activity).
  • Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).

Exclusion Criteria

  • changes in medication ≤6 wk prior to enrollment
  • major cardiovascular event or procedure ≤6 wk prior to enrollment
  • foot ulcers
  • advanced neuropathy
  • co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
  • fixed rate pacemaker
  • type 1 diabetes mellitus

Outcomes

Primary Outcomes

exercise capacity

Time Frame: baseline, 12 weeks

measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness

Secondary Outcomes

  • flow-mediated dilation(baseline, 12 weeks)
  • nitrite flux during exercise(baseline, 12 weeks)

Study Sites (1)

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