NCT03924479Completed
Respiratory Muscle Function in Heart Failure
Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 22 Mar 2024
Brief summary (registry, in English)
This study is being done because investigators are trying to determine how respiratory muscle and lung function influence the exercise responses in heart failure and healthy participants. Further, the heart failure patients will participate in an intervention to improve their respiratory muscle function to determine if this improves exercise capacity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 4 Feb 2019
- Start date
- 28 Nov 2018
- Primary completion date
- 21 Mar 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Heart failure
- NCT number
- NCT03924479
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 28 Nov 2018 to the primary completion date, 21 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of dangerous arrhythmias
- uremia, history of allergy to iodides
- diagnosis of liver disease
Lab values
- creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months)
Other
- body mass index \>35 kg/m2
- current smokers and/or smoking history \>15 pack years
- pregnant women
- impaired renal function
- individuals who are not able to engage in exercise
Who the study is looking for
- Clinical diagnosis of HFpEF.
- Patients with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis \>6 months).
- New York Heart Association class I-III.
- Current non-smokers with \<15 pack year history.
- Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).
Criteria the registry did not label
- Healthy subjects: Adults (≥21 years of age) in the absence of a history of HFpEF or HFrEF, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system. Controls will be matched for age and sex.
- All HFpEF patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.