Aortic Stenosis, SevereCardioFitNCT06818110
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
A study testing Exercise in people with Aortic Stenosis, Severe, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2025to 10 Dec 2025
- 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
- Participants may enter the study if ALL of the following apply:
- Age ≥ 18 years old
- Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- At least 14 days until planned to come in (TCI) date.
Who cannot join
- Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- Presyncope/syncope due to aortic stenosis
- Unstable angina/indication for urgent surgery
- Malignant arrhythmias
- Known pregnancy
- Patients declining surgery
Show all 9Show fewer
- Patients weight exceeds 160kg
- Patients unable to give informed consent
- Currently participating in another interventional clinical trial (although this will be reviewed on a case-by-case basis)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hopsitals Southampton NHS FT
Southampton, SO16 6YD
About this study
Official title: The Feasibility, Safety and Tolerability of an Exercise Training Programme in Patients with Severe Aortic Stenosis Prior to Aortic Valve Replacement Surgery: a Feasibility Trial
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement (AVR) in patients with severe aortic stenosis is feasible, safe, and tolerable.
Fitter patients have better surgical outcomes. Exercising post AVR surgery has been well documented and supported through cardiac rehabilitation programmes. However, there is limited evidence investigating exercising patients preoperatively, in part related to safety considerations in patients with severe aortic stenosis. If undertaking a SRETP before AVR in patients with severe aortic stenosis is shown to be feasible and safe, it provides a prehabilitation opportunity to enhance physical fitness with the aim of improving surgical outcomes.
Therefore, this trial will investigate whether SRETP (Prehabilitation) delivered before AVR in patients with severe aortic stenosis is safe \& feasible.
Read the detailed description
Single-centre Feasibility trial 15 patients
- Age ≥ 18 years old
- Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- At least 14 days until planned to come in (TCI) date
- Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- Presyncope/syncope due to aortic stenosis
- Unstable angina/indication for urgent surgery
- Malignant arrhythmias
- Known pregnancy
- Patients declining surgery
- Patients weight exceeds 160kg
- Patients unable to give informed consent
Intervention: 1) An in-hospital Structured Responsive Exercise-Training Programme (SRETP). The intervention will be delivered before surgery.
Feasibility Outcomes:
- Adherence to the intervention of ≥75%
- Tolerability of the intervention (minutes completed during the interval training) of ≥75%
- Adverse Events to SRETP
- Currently participating in another interventional clinical trial (this will be reviewed on a case-by-case basis)
Contraindications to SRETP:
- Acute systemic illness or fever
- Uncontrolled atrial or ventricular arrhythmias
- Uncontrolled sinus tachycardia (heart rate >120bpm)
- Acute pericarditis or myocarditis
- Decompensated heart failure
- Second or Third degree (complete) atrioventricular block without pacemaker
- Recent pulmonary embolism or deep vein thrombosis within 2 weeks
- Patients are unable to perform CPET (e.g. severe musculoskeletal conditions)
- Conditions
- Aortic Stenosis, Severe
- Being tested
- Exercise
- Keywords
- Exercise, Prehabilitation, Aortic valve replacement, Aortic stenosis, Cardiac surgery
- Medical subject headings
- Aortic Valve Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called An in-hospital Structured Responsive Exercise-Training Programme (SRETP)
The supervised exercise-training sessions will last <1 hour, and exercise-training intensities will be individually tailored to each participant using the results from their CPET. Participants will be screened prior to each session to ensure that it is safe to perform exercise. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high-intensity (50%∆) for a predetermined amount of time. Five minutes of freewheel cycling will be performed at the start and end of the protocol for a warm-up and cool-down. Exercise sessions can be terminated by the participant at any time. Participants will have continuous ECG and SpO2 monitoring throughout the training session. Vital signs will be taken before (some during) and after each training session.
| Study group | Role | What they receive |
|---|---|---|
| An in-hospital Structured Responsive Exercise-Training Programme (SRETP) | Other | Participants will participate in a structured, responsive, exercise training programme (SRETP) on a cycle ergometer. This training programme has been used in numerous international clinical trials, in several patient cohorts including cancer and lung disease.
The training programme will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity. This mode of exercise training is termed aerobic high-intensity interval training (HIIT). Exercise intensities during the interval exercise training program are specific to each participant and will be derived from the CPET. Moderate-intensity exercise is recognised as exercise below the anaerobic threshold. Participants will exercise at 80% of the work rate achieved at the anaerobic threshold (80%AT) for moderate-intensity exercise. High-intensity exercise is recognised as 50% of the difference between the "V" ̇O2 at the anaerobic threshold and the "V" ̇O2 peak (50%∆). Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes
- Adherence to the intervention ≥75%
- Tolerability of the intervention (minutes completed during the interval training) of ≥75%
- Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)
Measured: Baseline up to surgery
Secondary outcomes (3)
Endurance time
Change in time to limit of tolerance (endurance time) as measured by a constant work-rate exercise test
Measured: Baseline up to surgery
Change in objectively measured cardiopulmonary exercise testing variables
Measure a change in cardiopulmonary exercise variables. These include but are not limited to:
Oxygen uptake (VO2) at anaerobic threshold (AT)
Oxygen uptake at peak exercise
VE/VCO2 slope
Oxygen pulse
Measured: Baseline up to surgery
Health-related quality of life
Changes in health related quality of life measurements using validated questionnaires including:
EQ-5D-5L: A standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ-Q): A validated, brief, self-administered tool to measure changes in quality of life in patients with aortic stenosis undergoing an intervention.
Measured: Baseline up to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start28 Jan 2025
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818110
- Sponsor's protocol ID
- RHM CAR0655
- Acronym
- CardioFit
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Safety and Tolerability of an Exercise Training Programme in Patients with Severe Aortic Stenosis Prior to Aortic Valve Replacement Surgery: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT06818110
- Acronym / sponsor ID
- CardioFit / RHM CAR0655
- Conditions
- Aortic Stenosis, Severe
- Keywords
- Exercise, Prehabilitation, Aortic valve replacement, Aortic stenosis, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement (AVR) in patients with severe aortic stenosis is feasible, safe, and tolerable.
Fitter patients have better surgical outcomes. Exercising post AVR surgery has been well documented and supported through cardiac rehabilitation programmes. However, there is limited evidence investigating exercising patients preoperatively, in part related to safety considerations in patients with severe aortic stenosis. If undertaking a SRETP before AVR in patients with severe aortic stenosis is shown to be feasible and safe, it provides a prehabilitation opportunity to enhance physical fitness with the aim of improving surgical outcomes.
Therefore, this trial will investigate whether SRETP (Prehabilitation) delivered before AVR in patients with severe aortic stenosis is safe \& feasible.
Detailed description
Single-centre Feasibility trial 15 patients
- Age ≥ 18 years old
- Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- At least 14 days until planned to come in (TCI) date
- Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- Presyncope/syncope due to aortic stenosis
- Unstable angina/indication for urgent surgery
- Malignant arrhythmias
- Known pregnancy
- Patients declining surgery
- Patients weight exceeds 160kg
- Patients unable to give informed consent
Intervention: 1) An in-hospital Structured Responsive Exercise-Training Programme (SRETP). The intervention will be delivered before surgery.
Feasibility Outcomes:
- Adherence to the intervention of ≥75%
- Tolerability of the intervention (minutes completed during the interval training) of ≥75%
- Adverse Events to SRETP
- Currently participating in another interventional clinical trial (this will be reviewed on a case-by-case basis)
Contraindications to SRETP:
- Acute systemic illness or fever
- Uncontrolled atrial or ventricular arrhythmias
- Uncontrolled sinus tachycardia (heart rate >120bpm)
- Acute pericarditis or myocarditis
- Decompensated heart failure
- Second or Third degree (complete) atrioventricular block without pacemaker
- Recent pulmonary embolism or deep vein thrombosis within 2 weeks
- Patients are unable to perform CPET (e.g. severe musculoskeletal conditions)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| An in-hospital Structured Responsive Exercise-Training Programme (SRETP) | Other | Other: ExerciseParticipants will participate in a structured, responsive, exercise training programme (SRETP) on a cycle ergometer. This training programme has been used in numerous international clinical trials, in several patient cohorts including cancer and lung disease. The training programme will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity. This mode of exercise training is termed aerobic high-intensity interval training (HIIT). Exercise intensities during the interval exercise training program are specific to each participant and will be derived from the CPET. Moderate-intensity exercise is recognised as exercise below the anaerobic threshold. Participants will exercise at 80% of the work rate achieved at the anaerobic threshold (80%AT) for moderate-intensity exercise. High-intensity exercise is recognised as 50% of the difference between the "V" ̇O2 at the anaerobic threshold and the "V" ̇O2 peak (50%∆). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- At least 14 days until planned to come in (TCI) date.
Key exclusion criteria (9 listed)
- Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- Presyncope/syncope due to aortic stenosis
- Unstable angina/indication for urgent surgery
- Malignant arrhythmias
- Known pregnancy
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 |
|---|---|---|
| ExerciseAlso: An in-hospital Structured Responsive Exercise-Training Programme (SRETP)The supervised exercise-training sessions will last <1 hour, and exercise-training intensities will be individually tailored to each participant using the results from their CPET. Participants will be screened prior to each session to ensure that it is safe to perform exercise. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high-intensity (50%∆) for a predetermined amount of time. Five minutes of freewheel cycling will be performed at the start and end of the protocol for a warm-up and cool-down. Exercise sessions can be terminated by the participant at any time. Participants will have continuous ECG and SpO2 monitoring throughout the training session. Vital signs will be taken before (some during) and after each training session. | Other | An in-hospital Structured Responsive Exercise-Training Programme (SRETP) |
Primary outcome
Feasibility Outcomes
Time frame: Baseline up to surgery
1. Adherence to the intervention ≥75% 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75% 3. Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)
3 secondary outcomes
Endurance time
Time frame: Baseline up to surgery
Change in objectively measured cardiopulmonary exercise testing variables
Time frame: Baseline up to surgery
Health-related quality of life
Time frame: Baseline up to surgery
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 10 Feb 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Related trials for Aortic Stenosis, Severe
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Aortic Stenosis, Severe, run by University Hospital Southampton 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes (time frame: Baseline up to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.