NCT06551012Not yet recruiting
Neuromuscular Fatigability in Individuals With Heart Failure
The Influence of Active Muscle Mass and Nitrate Supplementation on Fatigability in Individuals With Heart Failure
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 determine the effect of nitrate supplementation on muscle fatigue during large muscle mass exercise in individuals with chronic heart failure (Part II), 3) understand the impact of exercise intolerance on quality of life in individuals with chronic heart failure (Part III). The main questions it aims to answer are: * Is muscle fatigue attenuated during exercise engaging a smaller vs larger muscle mass in individuals with chronic heart failure owing to lower central cardiopulmonary constraints? * Can supplementation with nitrate-rich beetroot juice reduce muscle fatigue and/or accelerate post-exercise recovery of muscle function in response to whole body exercise in individuals with heart failure? * What impact does exercise intolerance have on the lives of individuals with chronic heart failure? For Part I, researchers will compare muscle fatigue during single- and double-leg incremental cycling in individuals with chronic heart failure. For Part II, researchers will compare muscle fatigue in individuals with chronic heart failure during double-leg incremental cycling following a period of beetroot juice supplementation containing nitrate, or with a placebo drink consisting of beetroot juice with nitrate extracted. For Part III, semi-structured interviews will be conducted to investigate the symptoms associated with performing physical activity and on the impact of exercise intolerance on quality of life in individuals with chronic heart failure.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- 1 May 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Newcastle University
- Diseases
- Heart failure
- NCT number
- NCT06551012
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 1 May 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no 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.
Prior treatment
- 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)
- Currently taking part in any other study.
Other illness
- 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%).
Other
- An electrically implanted device (e.g., pacemaker, left ventricular assist device).
- 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.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.