Heart Failure Clinical Trial
— EXT-HFOfficial title:
Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit
NCT number | NCT03648762 |
Other study ID # | O0834-R |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2017 |
Est. completion date | September 30, 2019 |
Verified date | October 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to better understand how skeletal muscle is affected by
heart failure, and to determine how exercise interventions impact skeletal muscle and
functional capacity. While many think of heart failure as a disease that only affects the
heart, doctors now believe that it actually affects the whole body, including skeletal
muscle, such as the muscles of your arms and legs. Therefore, while many people with heart
failure develop weakness and reduced exercise capacity, this may be related more to their
skeletal muscle than their weakened hearts. This study looks directly at how exercise might
change skeletal muscle and possibly improve quality of life in heart failure patients.
As part of the study participants will take part in a cardiopulmonary exercise test, lower
body strength testing, breathing assessment, a muscle biopsy (optional), blood draw, and DXA
scanning (to assess lean body mass). Participants with heart failure will complete 1 of 3
exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory) for 12
weeks and will be assessed pre and post to determine if any differences occur in their
skeletal muscle and functional capacity as part of the exercise intervention.
Status | Completed |
Enrollment | 52 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Heart failure - Echo in two years - NYHA class II or III - Optimal therapy according to AHA/ACC and HFSA HF guidelines; unless documented by a provider for variation. Exclusion Criteria: - Major cardiovascular event or procedure within the prior 6 weeks. - Dementia - Severe COPD (FEV1<50%), - End-stage malignancy - Severe valvular heart disease that would make exercise un safe - Orthopedic limitation preventing exercise - Any bleeding disorder that would contraindicate safe exercise - Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months - Psychiatric hospitalization within the last 3 months - ICD device with heart rate limits that prohibit exercise assessments or exercise training. - Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate. - Chronic use of oral corticosteroids or medications that affect muscle function. - Notably, patients using statins will be eligible, and this will be factored into the randomization and analysis. - Chronic ETOH or drug dependency shown within the last year |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inflammation - C-reactive protein | Inflammation - C-reactive protein will be measured through blood | baseline and through study completion an average of 14 weeks | |
Other | dual-energy x-ray absorptiometry | dual-energy x-ray absorptiometry will look at muscle mass change in kg | Baseline and through study completion an average of 14 weeks | |
Primary | Oxygen uptake (VO2) peak | a cardiopulmonary exercise test will be performed to determined peak VO2 in ML/KG/Min | baseline and through study completion an average of 14 weeks | |
Primary | One Repetition Maximum- Leg press | Leg press will be performed on the Keiser Leg press and measured in kilograms (kg) | baseline and through study completion an average of 14 weeks | |
Secondary | Gene Expression - proteolytic genes (Forkhead box O3 [Foxo3] and Ubiquitin) | Assessment of proteolytic genes (Forkhead box O3 [Foxo3] and Ubiquitin) through assessment real-time -polymerase chain reaction of skeletal muscle biopsy measured in relative expression. | baseline and through study completion an average of 14 weeks | |
Secondary | Gene Expression anabolic genes Peroxisome proliferator-activated receptor gamma coactivator 1-alpha and Insulin-like growth factor 1 | Gene Expression anabolic genes Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1 ) and Insulin-like growth factor 1 (IGF-1) through assessment real-time -polymerase chain reaction of skeletal muscle biopsy measured in relative expression. | baseline and through study completion an average of 14 weeks |
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