Limitations of Aerobic Capacity in Chronic Heart Failure
Role and Implications of Central Fatigue Limiting Aerobic Capacity in Chronic Heart Failure: The Head vs. Heart Study
1 other identifier
interventional
91
1 country
1
Brief Summary
This study will use a novel CPX test that incorporates instantaneous assessment of maximal isokinetic cycling power at V̇O2peak to elucidate the mechanisms that limit V̇O2peak in CHF, and compare these responses with age-matched controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2024
CompletedOctober 26, 2024
October 1, 2024
4.7 years
March 27, 2020
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum cycling power
Power (watts)
One week
Power reserve at V̇O2peak
Power (watts)
One week
V̇O2peak with opioid treatment
ml/kg/min
One week
Secondary Outcomes (4)
Echocardiography
One week
Spirometry
One week
Electrical activity of the muscles (EMG)
One week
Muscle oxygenation (NIRS)
One week
Study Arms (2)
Chronic Heart Failure
EXPERIMENTALAge-matched healthy controls
ACTIVE COMPARATORInterventions
This study will use our novel CPX test that incorporates instantaneous assessment of maximal isokinetic cycling power at V̇O2peak to elucidate the mechanisms that limit V̇O2peak in CHF, and compare these responses with age-matched controls.
Eligibility Criteria
You may qualify if:
- Patients with NYHA class I-III
- Stable CHF of at least 3 months duration
- On optimally tolerated medication for CHF
- No contraindications for cycling exercise
- Able to give informed consent
You may not qualify if:
- Class IV CHF
- Any contraindications to exercise
- Co-morbidities: significant COPD (FEV1\<50%), severe renal disease (eGFR\<20) or primary pulmonary hypertension as a co-morbidity
- Unable to give informed consent
- Current diagnosis of cancer, inflammatory or musculoskeletal disease (e.g. rheumatoid arthritis), on-going infection or sepsis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS16 5AR, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 27, 2020
First Posted
April 2, 2020
Study Start
December 1, 2019
Primary Completion
August 25, 2024
Study Completion
October 18, 2024
Last Updated
October 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share