Status:
NOT_YET_RECRUITING
Neuromuscular Fatigability in Individuals With Heart Failure
Lead Sponsor:
Newcastle University
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Brief summary The aims of this project are to 1) characterise muscle fatigue in individuals with chronic heart failure during exercise involving a smaller and larger muscle mass (Part I), 2) to deter...
Detailed Description
Background: Exercise intolerance is a hallmark symptom of chronic heart failure with reduced ejection fraction (HFrEF) and is associated with reduced quality of life as well as being a strong prognos...
Eligibility Criteria
Inclusion
- Patients with a left ventricular ejection fraction \< 40% who have been diagnosed for at least 3 months.
- Classified according to New York Heart Association (NYHA) class II-III.
- Clinically stable and receiving optimal medical treatment.
- Aged ≥ 45 years old.
- Ability to read, write and converse in English without the support of an interpreter.
- Willingness to undertake physical activity with no contraindications to physical activity and capable of performing activities of daily living independently, without the use of a walking aid.
- Able to provide written informed consent.
Exclusion
- An electrically implanted device (e.g., pacemaker, left ventricular assist device).
- Uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery up to 3 months previously.
- Receiving antacids or proton pump, xanthine oxidase, or phosphodiesterase inhibitors which affect the reduction of nitrate to nitrite and nitrite to nitric oxide.
- Treated with organic nitrates (e.g., trinitroglycerin)
- Major multi-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g., patients with a terminal diagnosis of cancer, patients in receipt of oxygen therapy or oxygen saturation at rest \<92%).
- Obesity (body mass index \> 30 kg/m2).
- Current smoker.
- Presented with severe symptoms requiring urgent assessment and stabilisation (e.g., breathlessness at rest, hypotension, confusion).
- Severe physical disability preventing them from functioning independently;
- Unable to provide informed consent.
- Currently taking part in any other study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06551012
Start Date
May 1 2025
End Date
April 1 2027
Last Update
March 25 2025
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