Congenital Heart DiseaseACE-CHDNCT07700459
Exercise Prehabilitation in Congenital Heart Disease
A study testing Exercise prehabilitation in people with Congenital Heart Disease and Cardiac Surgery, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD). Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood. As people with CHD get older, many need repeated heart operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Cardiac Surgery
- What is being tested?
- Exercise prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with congenital heart disease requiring cardiac surgery via sternotomy or thoracotomy.
- Capacity to provide informed consent.
- Ability and willingness to engage in exercise-based interventions.
- Peak VO2 <30ml/kg/min at preoperative exercise assessment.
- Participant reached peak VO2 in preoperative exercise assessment (RER >1.0).
- Ability to communicate in English.
Who cannot join
- Surgery is scheduled for a date that precludes participation in the programme - surgical date is <9 weeks away.
- Pregnancy of <6 months postpartum.
- History of pneumothorax within the last 3 months.
- Resting oxygen saturations <94%.
- Uncorrected right-to-left shunt with exercise.
- Fontan physiology.
Show all 11Show fewer
- Pulmonary hypertension.
- Critical valvular obstruction.
- Sustained ventricular arrhythmia.
- Severe aortic dilatation (>45mm in Marfan syndrome or hereditary aortopathy, >50mm in bicuspid or tricuspid aortic valves).
- The oldest person operated upon by the ACHD service was 78 years old. Upper age is not an exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
About this study
Official title: A Randomised-controlled Trial to Assess the Impact of Prehabilitation and a Structured Exercise Programme on Cardiorespiratory Performance in Adults Awaiting Elective Surgery for Congenital Heart Disease: The ACE-CHD Trial.
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD).
Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.
Read more
As people with CHD get older, many need repeated heart operations. It is known from other areas of medicine that "prehabilitation" - a short, structured exercise programme completed before surgery - can improve fitness and help patients cope better with major operations. However, this approach has never been tested in adults with CHD. The investigators are running a randomised controlled trial to find out whether a prehabilitation programme can improve physical fitness before heart surgery in adults with CHD.
Participants will be randomly assigned to usual care or a prehabilitation group. Those in the prehabilitation group will follow a tailored, supervised exercise plan for several weeks before surgery.
All patients undergoing cardiac surgery routinely complete a cardiopulmonary exercise test (CPET) as part of their standard pre-operative assessment. CPET is a well-established test that shows how the heart and lungs respond to increasing levels of exercise. During the test, participants exercise on a bike while their breathing, heart rate, and overall physiological response are continuously monitored.
The results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group.
Exercise levels prescribed in the study will not exceed the intensity already safely achieved during the routine CPET, ensuring that activity remains within clinically assessed limits.
Participants in the trial will complete an additional second CPET following the trial period.
The key question is whether a tailored exercise programme can improve fitness in adults with CHD before heart surgery, and whether this approach is feasible, acceptable and practical to deliver, including successful recruitment and measurable physiological improvements.
- Conditions
- Congenital Heart Disease, Cardiac Surgery
- Being tested
- Exercise prehabilitation
- Keywords
- Congenital heart disease, Prehabilitation, Cardiac surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise prehabilitationOther
Participants undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist, individualised to CPET results, baseline activity, and patient capability. It includes aerobic (progressive RPE-based, targeting 150-300 min/week moderate intensity with warm-up/cool-down), respiratory (inspiratory muscle training), and resistance training (major muscle groups, 15-30 repetitions, plus handgrip exercises). Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support. Anxiety is addressed by the research team, with referral to psychology if required. Adherence is supported with at least fortnightly contact (phone/email/text). All participants undergo repeat CPET at 7-9 weeks. Participants are encouraged to continue exercises until surgery where feasible.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Arm | Experimental | Participants will undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist. The programme is individualised based on CPET results, baseline activity, and patient capability. It includes cardiovascular, respiratory, and resistance training. Aerobic exercise is prescribed using a progressive Rating of Perceived Exertion (RPE) approach, targeting 150-300 minutes/week of moderate-intensity activity in line with ESC guidance, with warm-up and cool-down. Respiratory training is delivered using an inspiratory muscle trainer. Resistance training targets major muscle groups (15-30 repetitions) using bands, with additional handgrip exercises. Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support. Receives: Other: Exercise prehabilitation |
| Control Arm | No intervention | Standard preoperative management, which includes routine surgical clinic assessments, medical clinic appointments, preoperative nursing reviews and access to the ACHD nurse helpline as normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up.
The primary outcome will be the within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and at follow-up.
Measured: Baseline and follow-up CPETs (up to 9 weeks apart).
Secondary outcomes (1)
Individual change in forced vital capacity (litres) at baseline and follow-up.
Best of three acceptable attempts after usual inhaled medications (if taken) at baseline and follow-up. This is a routine measurement on a CPET at LHCH.
Measured: Baseline and follow-up CPETs (up to 9 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start28 Aug 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-centre, prospective, outcome-blinded, feasibility, randomised controlled trial with a qualitative substudy, assessing prehabilitation in ACHD patients, excluding patients with high initial fitness levels, and hence less chance of clinical benefit from exercise prehabilitation impact, referred for elective cardiac surgery, will be conducted at Liverpool Heart and Chest Hospital (LHCH).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool John Moores University
- Responsible party
- Sponsor
- Investigators
- Julia D Jones, MD, Principal investigator, Liverpool Heart and Chest Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700459
- Sponsor's protocol ID
- 1696
- Acronym
- ACE-CHD
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pooled data will be published.
Publications
NHS Liverpool Clinical Commissioning Group. One Liverpool Strategy 2019-2024. In: NHS England, ed. Online; 2019.
Department of Health and Social Care. Fit for the future: 10 Year Health Plan for England. In: Care DoHaS, ed. Online; 2025.
NHS England. NHS Long Term Plan. In: England N, ed; 2019.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.
PubMed 32860412Ferrero P, Piazza I, Poggioli G, Chessa M, Lorenzelli F. Long-term effects of physical training on cardiopulmonary exercise parameters in young patients with congenital heart diseases. Cardiol Young. 2024 Apr;34(4):831-837. doi: 10.1017/S1047951123003621. Epub 2023 Oct 23.
PubMed 37869879Bargnes V 3rd, Davidson S, Talbot L, Jin Z, Poppers J, Bergese SD. Start Strong, Finish Strong: A Review of Prehabilitation in Cardiac Surgery. Life (Basel). 2024 Jun 29;14(7):832. doi: 10.3390/life14070832.
PubMed 39063586McIsaac DI, Kidd G, Gillis C, Branje K, Al-Bayati M, Baxi A, Grudzinski AL, Boland L, Veroniki AA, Wolfe D, Hutton B. Relative efficacy of prehabilitation interventions and their components: systematic review with network and component network meta-analyses of randomised controlled trials. BMJ. 2025 Jan 22;388:e081164. doi: 10.1136/bmj-2024-081164.
PubMed 39843215Assouline B, Cools E, Schorer R, Kayser B, Elia N, Licker M. Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Ann Am Thorac Soc. 2021 Apr;18(4):678-688. doi: 10.1513/AnnalsATS.202002-183OC.
PubMed 33030962Shen F, Kim HJ, Lee NK, Chun HJ, Chang BS, Lee CK, Yeom JS. The influence of hand grip strength on surgical outcomes after surgery for degenerative lumbar spinal stenosis: a preliminary result. Spine J. 2018 Nov;18(11):2018-2024. doi: 10.1016/j.spinee.2018.04.009. Epub 2018 Apr 18.
PubMed 29679727Hunt DR, Rowlands BJ, Johnston D. Hand grip strength--a simple prognostic indicator in surgical patients. JPEN J Parenter Enteral Nutr. 1985 Nov-Dec;9(6):701-4. doi: 10.1177/0148607185009006701.
PubMed 4068194Park HJ, Kim SM, Kim HR, Ji W, Choi CM. The value of preoperative spirometry testing for predicting postoperative risk in upper abdominal and thoracic surgery assessed using big-data analysis. J Thorac Dis. 2020 Aug;12(8):4157-4167. doi: 10.21037/jtd-19-2687.
PubMed 32944327Amirkhosravi F, Allenson KC, Moore LW, Kolman JM, Foster M, Hsu E, Sasangohar F, Dhala A. Multimodal prehabilitation and postoperative outcomes in upper abdominal surgery: systematic review and meta-analysis. Sci Rep. 2024 Jul 11;14(1):16012. doi: 10.1038/s41598-024-66633-6.
PubMed 38992072Roxburgh BH, Cotter JD, Campbell HA, Reymann U, Wilson LC, Gwynne-Jones D, van Rij AM, Thomas KN. Physiological relationship between cardiorespiratory fitness and fitness for surgery: a narrative review. Br J Anaesth. 2023 Feb;130(2):122-132. doi: 10.1016/j.bja.2022.10.039. Epub 2022 Dec 16.
PubMed 36529576Rose GA, Davies RG, Appadurai IR, Williams IM, Bashir M, Berg RMG, Poole DC, Bailey DM. 'Fit for surgery': the relationship between cardiorespiratory fitness and postoperative outcomes. Exp Physiol. 2022 Aug;107(8):787-799. doi: 10.1113/EP090156. Epub 2022 Jun 5.
PubMed 35579479
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised-controlled Trial to Assess the Impact of Prehabilitation and a Structured Exercise Programme on Cardiorespiratory Performance in Adults Awaiting Elective Surgery for Congenital Heart Disease: The ACE-CHD Trial.
- ClinicalTrials.gov ID
- NCT07700459
- Acronym / sponsor ID
- ACE-CHD / 1696
- Conditions
- Congenital Heart Disease, Cardiac Surgery
- Keywords
- Congenital heart disease, Prehabilitation, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool John Moores University
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD).
Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.
As people with CHD get older, many need repeated heart operations. It is known from other areas of medicine that "prehabilitation" - a short, structured exercise programme completed before surgery - can improve fitness and help patients cope better with major operations. However, this approach has never been tested in adults with CHD. The investigators are running a randomised controlled trial to find out whether a prehabilitation programme can improve physical fitness before heart surgery in adults with CHD.
Participants will be randomly assigned to usual care or a prehabilitation group. Those in the prehabilitation group will follow a tailored, supervised exercise plan for several weeks before surgery.
All patients undergoing cardiac surgery routinely complete a cardiopulmonary exercise test (CPET) as part of their standard pre-operative assessment. CPET is a well-established test that shows how the heart and lungs respond to increasing levels of exercise. During the test, participants exercise on a bike while their breathing, heart rate, and overall physiological response are continuously monitored.
The results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group.
Exercise levels prescribed in the study will not exceed the intensity already safely achieved during the routine CPET, ensuring that activity remains within clinically assessed limits.
Participants in the trial will complete an additional second CPET following the trial period.
The key question is whether a tailored exercise programme can improve fitness in adults with CHD before heart surgery, and whether this approach is feasible, acceptable and practical to deliver, including successful recruitment and measurable physiological improvements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This single-centre, prospective, outcome-blinded, feasibility, randomised controlled trial with a qualitative substudy, assessing prehabilitation in ACHD patients, excluding patients with high initial fitness levels, and hence less chance of clinical benefit from exercise prehabilitation impact, referred for elective cardiac surgery, will be conducted at Liverpool Heart and Chest Hospital (LHCH).
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Arm | Experimental | Other: Exercise prehabilitationParticipants will undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist. The programme is individualised based on CPET results, baseline activity, and patient capability. It includes cardiovascular, respiratory, and resistance training. Aerobic exercise is prescribed using a progressive Rating of Perceived Exertion (RPE) approach, targeting 150-300 minutes/week of moderate-intensity activity in line with ESC guidance, with warm-up and cool-down. Respiratory training is delivered using an inspiratory muscle trainer. Resistance training targets major muscle groups (15-30 repetitions) using bands, with additional handgrip exercises. Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support. |
| Control Arm | No intervention | –Standard preoperative management, which includes routine surgical clinic assessments, medical clinic appointments, preoperative nursing reviews and access to the ACHD nurse helpline as normal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with congenital heart disease requiring cardiac surgery via sternotomy or thoracotomy.
- Capacity to provide informed consent.
- Ability and willingness to engage in exercise-based interventions.
- Peak VO2 <30ml/kg/min at preoperative exercise assessment.
- Participant reached peak VO2 in preoperative exercise assessment (RER >1.0).
Key exclusion criteria (11 listed)
- Surgery is scheduled for a date that precludes participation in the programme - surgical date is <9 weeks away.
- Pregnancy of <6 months postpartum.
- History of pneumothorax within the last 3 months.
- Resting oxygen saturations <94%.
- Uncorrected right-to-left shunt with exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise prehabilitationParticipants undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist, individualised to CPET results, baseline activity, and patient capability. It includes aerobic (progressive RPE-based, targeting 150-300 min/week moderate intensity with warm-up/cool-down), respiratory (inspiratory muscle training), and resistance training (major muscle groups, 15-30 repetitions, plus handgrip exercises). Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support. Anxiety is addressed by the research team, with referral to psychology if required. Adherence is supported with at least fortnightly contact (phone/email/text). All participants undergo repeat CPET at 7-9 weeks. Participants are encouraged to continue exercises until surgery where feasible. | Other | Prehabilitation Arm |
Primary outcome
Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up.
Time frame: Baseline and follow-up CPETs (up to 9 weeks apart).
The primary outcome will be the within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and at follow-up.
1 secondary outcome
Individual change in forced vital capacity (litres) at baseline and follow-up.
Time frame: Baseline and follow-up CPETs (up to 9 weeks apart)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- BackgroundNHS Liverpool Clinical Commissioning Group. One Liverpool Strategy 2019-2024. In: NHS England, ed. Online; 2019.
- BackgroundDepartment of Health and Social Care. Fit for the future: 10 Year Health Plan for England. In: Care DoHaS, ed. Online; 2025.
- BackgroundNHS England. NHS Long Term Plan. In: England N, ed; 2019.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Background: PubMed 32860412Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.
- Background: PubMed 37869879Ferrero P, Piazza I, Poggioli G, Chessa M, Lorenzelli F. Long-term effects of physical training on cardiopulmonary exercise parameters in young patients with congenital heart diseases. Cardiol Young. 2024 Apr;34(4):831-837. doi: 10.1017/S1047951123003621. Epub 2023 Oct 23.
- Background: PubMed 39063586Bargnes V 3rd, Davidson S, Talbot L, Jin Z, Poppers J, Bergese SD. Start Strong, Finish Strong: A Review of Prehabilitation in Cardiac Surgery. Life (Basel). 2024 Jun 29;14(7):832. doi: 10.3390/life14070832.
- Background: PubMed 39843215McIsaac DI, Kidd G, Gillis C, Branje K, Al-Bayati M, Baxi A, Grudzinski AL, Boland L, Veroniki AA, Wolfe D, Hutton B. Relative efficacy of prehabilitation interventions and their components: systematic review with network and component network meta-analyses of randomised controlled trials. BMJ. 2025 Jan 22;388:e081164. doi: 10.1136/bmj-2024-081164.
- Background: PubMed 33030962Assouline B, Cools E, Schorer R, Kayser B, Elia N, Licker M. Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Ann Am Thorac Soc. 2021 Apr;18(4):678-688. doi: 10.1513/AnnalsATS.202002-183OC.
- Background: PubMed 29679727Shen F, Kim HJ, Lee NK, Chun HJ, Chang BS, Lee CK, Yeom JS. The influence of hand grip strength on surgical outcomes after surgery for degenerative lumbar spinal stenosis: a preliminary result. Spine J. 2018 Nov;18(11):2018-2024. doi: 10.1016/j.spinee.2018.04.009. Epub 2018 Apr 18.
- Background: PubMed 4068194Hunt DR, Rowlands BJ, Johnston D. Hand grip strength--a simple prognostic indicator in surgical patients. JPEN J Parenter Enteral Nutr. 1985 Nov-Dec;9(6):701-4. doi: 10.1177/0148607185009006701.
- Background: PubMed 32944327Park HJ, Kim SM, Kim HR, Ji W, Choi CM. The value of preoperative spirometry testing for predicting postoperative risk in upper abdominal and thoracic surgery assessed using big-data analysis. J Thorac Dis. 2020 Aug;12(8):4157-4167. doi: 10.21037/jtd-19-2687.
- Individual participant dataSharing planned: No. Pooled data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia D Jones, MD principal investigator
Liverpool Heart and Chest Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise prehabilitation in people with Congenital Heart Disease and Cardiac Surgery, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elen H Hughes, MBBCh (+44 01516001616, elen.hughes@lhch.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up. (time frame: Baseline and follow-up CPETs (up to 9 weeks apart).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07700459, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.