Exercise, Heart Failure, and Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: aerobic exercise training


Participation Criteria
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Eligibility Criteria
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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: smoking 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: heart failure<br>aerobic exercise training | Behavioral: aerobic exercise training<br>* 12 weeks of supervised aerobic exercise training<br>|
| Other: heart failure plus type 2 diabetes<br>aerobic exercise training | Behavioral: aerobic exercise training<br>* 12 weeks of supervised aerobic exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity | measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation | brachial artery flow-mediated dilation | baseline, 12 weeks | 
| nitrite flux during exercise | changes in plasma nitrite during exercise | baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, aerobic exercise