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WithdrawnNCT02122835Updated Jun 15, 2023

Exercise, Heart Failure, and Type 2 Diabetes

An interventional study of aerobic exercise training in Heart Failure and Type 2 Diabetes, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Lack of funding/patient availability
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
50 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Type 2 Diabetes

Keywords

  • exercise
  • aerobic exercise
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

Browse Heart Failure studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    heart failure

    aerobic exercise training

    Behavioral: aerobic exercise training

  • Other
    heart failure plus type 2 diabetes

    aerobic exercise training

    Behavioral: aerobic exercise training

Interventions

  • Behavioralaerobic exercise training

    12 weeks of supervised aerobic exercise training

06

What researchers measure

Primary outcomes

  1. exercise capacity

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

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. flow-mediated dilation

    brachial artery flow-mediated dilation

    Time frame: baseline, 12 weeks

  2. nitrite flux during exercise

    changes in plasma nitrite during exercise

    Time frame: baseline, 12 weeks

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02122835
Lead sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Apr 25, 2014
Start date
Feb 2012
Primary completion
Sep 2014
Last update
Jun 15, 2023

Study contacts

William Kraus, MD
principal investigator · Duke University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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