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Search / Trial NCT06551012

Neuromuscular Fatigability in Individuals With Heart Failure

Launched by NEWCASTLE UNIVERSITY · Aug 9, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Exercise Physiology Fatigability

ClinConnect Summary

This clinical trial is studying how muscle fatigue affects people with heart failure, particularly those whose hearts don't pump blood as effectively as they should. The researchers want to understand how exercise affects muscle fatigue when using different muscle groups and whether taking beetroot juice, which contains nitrates, can help reduce this fatigue. They will also explore how difficulty with exercise impacts the quality of life for individuals living with heart failure.

To participate in this study, individuals must be at least 45 years old and have a specific type of heart failure, known as reduced ejection fraction, for at least three months. They should be feeling stable, receiving proper treatment, and able to perform daily activities independently. Participants will engage in exercise tests and may try beetroot juice or a placebo drink to see how it affects their muscle fatigue. Throughout the study, the researchers will also conduct interviews to learn more about the participants' experiences and challenges with physical activity.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Newcastle University

Newcastle University is a leading research institution located in the United Kingdom, renowned for its commitment to advancing healthcare through innovative clinical trials and scientific research. The university's Clinical Trials Unit plays a pivotal role in the design, coordination, and execution of high-quality clinical studies, focusing on a wide range of therapeutic areas. With a multidisciplinary team of experts, Newcastle University fosters collaboration between academia, industry, and healthcare providers, ensuring that research findings translate into meaningful advancements in patient care. Its dedication to excellence and ethical standards positions Newcastle University as a trusted sponsor in the clinical research landscape.

Locations

Patients applied

0 patients applied

Trial Officials

Callum Brownstein, PhD

Principal Investigator

Newcastle University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported