Heart FailureNCT02122835
Exercise, Heart Failure, and Type 2 Diabetes
A study testing aerobic exercise training in people with Heart Failure and Type 2 Diabetes, run by Duke University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Heart Failure, Type 2 Diabetes
- What is being tested?
- aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes
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.
- Conditions
- Heart Failure, Type 2 Diabetes
- Being tested
- aerobic exercise training
- Keywords
- exercise, aerobic exercise
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise trainingBehavioural
12 weeks of supervised aerobic exercise training
| Study group | Role | What they receive |
|---|---|---|
| heart failure | Other | aerobic exercise training Receives: Behavioral: aerobic exercise training |
| heart failure plus type 2 diabetes | Other | aerobic exercise training Receives: Behavioral: aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness
Measured: baseline, 12 weeks
Secondary outcomes (2)
flow-mediated dilation
brachial artery flow-mediated dilation
Measured: baseline, 12 weeks
nitrite flux during exercise
changes in plasma nitrite during exercise
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
Why it stopped: Lack of funding/patient availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122835
- Sponsor's protocol ID
- Pro00032063
- Status last verified
- May 2015
- First submitted
- 18 Apr 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02122835
- Acronym / sponsor ID
- Pro00032063
- Conditions
- Heart Failure, Type 2 Diabetes
- Keywords
- exercise, aerobic exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding/patient availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heart failure | Other | Behavioral: aerobic exercise trainingaerobic exercise training |
| heart failure plus type 2 diabetes | Other | Behavioral: aerobic exercise trainingaerobic exercise training |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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).
Key exclusion criteria (8 listed)
- smoking
- changes in medication ≤6 wk prior to enrollment
- major cardiovascular event or procedure ≤6 wk prior to enrollment
- foot ulcers
- advanced neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise training12 weeks of supervised aerobic exercise training | Behavioural | heart failure, heart failure plus type 2 diabetes |
Primary outcome
exercise capacity
Time frame: baseline, 12 weeks
measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness
2 secondary outcomes
flow-mediated dilation
Time frame: baseline, 12 weeks
nitrite flux during exercise
Time frame: baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise training in people with Heart Failure and Type 2 Diabetes, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.