Aortic StenosisRECOVER-TAVRNCT02921880
Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement?
A study testing Cardiac Rehabilitation in people with Aortic Stenosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 13 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe symptomatic aortic stenosis accepted for Trans Catheter Aortic Valve Replacement
- Age ≥75 years;
- Participant able and willing to give written informed consent;
- Participant able (in the Investigator's opinion) and willing to comply with all study requirements.
Who cannot join
- Subjects may not enter the study if ANY of the following apply:
- Intervention deemed inappropriate due to co-morbidity or frailty;
- Life expectancy less than one year due to co-morbidity;
- Previous AVR or TAVI;
- Predominant aortic regurgitation (AR).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
Uxbridge, Middlesex, UB9 6JH
About this study
The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.
Read the detailed description
BACKGROUND
Aortic stenosis is the most common form of valvular heart disease in the elderly and is associated with high morbidity and mortality once cardiac symptoms develop (1). In patients who are at high risk for serious complications during or after surgery, Transcatheter Aortic Valve Implantation (TAVI) has been shown to result in reductions in mortality and improvement in quality of life compared with medical therapy (2, 3).
Due to the ageing and increasingly complex nature of patients with aortic stenosis, frailty and functional assessment has become a high-priority theme within patient management. Frailty is a term widely used to describe a multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability. Several publications deal with the impact of frailty on mortality and morbidity in the elderly population. Functional status is evaluated by the ability to undertake Activities of Daily Living (ADL) and it has been demonstrated that frailty and the onset of dependence in ADL are strongly associated.
4.2 PRE-CLINICAL DATA/CLINICAL DATA
Cardiac rehabilitation is a complex intervention offered to patients with heart disease and includes components of health education, advice on cardiovascular risk reduction, physical activity and stress management. Cardiac rehabilitation and physical activity are recommended treatments after cardiac valve surgery and positively improves morbidity, exercise capacity and quality of life or emotional well-being. The National Institute for Healthcare Excellence and The Department of Health and wider European guidelines agree that patients who have received heart valve replacements will benefit from cardiac rehabilitation.
4.3 STUDY RATIONALE AND RISK/BENEFIT ANALYSIS
A literature search has not revealed any publications which specifically outline the impact of receiving a programme of cardiac rehabilitation, following TAVR and this study aims to address that question. The ethical dilemma of conducting research in elderly patients who have undergone TAVR can be associated with clinical trials in other elderly populations. The dilemma consists of the need to develop new and better treatment options for a particular group of patients whilst protecting the patient from harm. We anticipate that this study will allow us to understand the feasibility of undertaking this study in a group of patients who have agreed to participate in a research study prior to the TAVR procedure. The pilot study will help us to understand the logistics of providing a cardiac rehabilitation programme for patients and the data we generate will allow us to understand if there are any benefits related to functional, independence, frailty and emotional domains for this patient group. The outcomes from this pilot study may allow us to plan future studies with the aim of developing appropriate guidelines related to the provision of cardiac rehabilitation for this patient group.
4.4 MANAGEMENT OF POTENTIAL STUDY RISKS
Patients who are eligible for TAVR, as determined by the multi-disciplinary team, will be seen in the out-patient clinic or in-patient area by the Research Nurse Manager or delegated research nurse. Full informed consent will be obtained before any research intervention is undertaken. Functional, independence, frailty and emotional assessment will include 6 minute walk teat, 4m gait speed walk, hand grip strength, questionnaires and cognitive assessment.
Patients will undergo TAVR as per routine practice and they will be discharged when safe to do so. The research nurse team will collect clinical data during the admission. All patients will attend clinic for review at 4 weeks post implant, research consent will be reaffirmed and the patients will be randomised to receive a cardiac rehabilitation programme or standard of care.
A personalised programme of cardiac rehabilitation will be developed by expert physiotherapists. Patients in the cardiac rehab group will be assessed for the cardiac rehabilitation prior to any intervention taking place. Patients are monitored during exercise and full emergency equipment is available should there be an emergency.
Patients who are in the standard of care group will have access to the TAVR nurse specialist as well as the designated Consultant and research nurse team to ask any advice at any time.
- Conditions
- Aortic Stenosis
- Being tested
- Cardiac Rehabilitation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Patients will return to the out-patient clinic at 4 weeks post - TAVR and research consent will be re-affirmed. Patients will be randomised to receive a programme of cardiac rehabilitation or routine care at this point. Patients randomised to receive cardiac rehabilitation will meet the cardiac rehab team and undergo baseline assessment for the programme. This involves recording height, weight, blood pressure, oxygen saturation and heart rate and rhythm. An individualised programme will be established to meet the needs of each patient. The patients will undergo a 6 week programme of cardiac rehab. Patients who are not allocated to the intervention group will not receive a cardiac programme and will have access to the TAVR nurse specialist team as would be usual care. Receives: Other: Cardiac Rehabilitation |
| Standard of care | No intervention | 15 patients will be randomised to receive a programme of cardiac rehabilitation, and 15 patients will receive standard of care which does not include a routine rehabilitation programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients willing to undertake cardiac rehabilitation following TAVR.
Measured: 6 months
Secondary outcomes (3)
Functional capacity by 4 metre gait speed.
Measured at baseline, 6 weeks, 3 months and 6 months.
Measured: 6 months
Frailty assessment via the FRIED criteria.
Measured at baseline, 6 weeks, 3 months and 6 months.
Measured: 6 months
Hospital Anxiety and Depression score
Measured at baseline, 6 weeks, 3 months and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startMay 2016
- Primary completion1 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921880
- Sponsor's protocol ID
- 16/OO/0687
- Acronym
- RECOVER-TAVR
- Status last verified
- Nov 2017
- First submitted
- 28 Sep 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.
PubMed 18848134Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.
PubMed 21969017Rogers P, Al-Aidrous S, Banya W, Haley SR, Mittal T, Kabir T, Panoulas V, Raja S, Bhudia S, Probert H, Prendergast C, Spence MS, Davies S, Moat N, Taylor RS, Dalby M. Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group. Pilot Feasibility Stud. 2018 Dec 13;4:185. doi: 10.1186/s40814-018-0363-8. eCollection 2018.
PubMed 30564436
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement?
- ClinicalTrials.gov ID
- NCT02921880
- Acronym / sponsor ID
- RECOVER-TAVR / 16/OO/0687
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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 aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.
Detailed description
BACKGROUND
Aortic stenosis is the most common form of valvular heart disease in the elderly and is associated with high morbidity and mortality once cardiac symptoms develop (1). In patients who are at high risk for serious complications during or after surgery, Transcatheter Aortic Valve Implantation (TAVI) has been shown to result in reductions in mortality and improvement in quality of life compared with medical therapy (2, 3).
Due to the ageing and increasingly complex nature of patients with aortic stenosis, frailty and functional assessment has become a high-priority theme within patient management. Frailty is a term widely used to describe a multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability. Several publications deal with the impact of frailty on mortality and morbidity in the elderly population. Functional status is evaluated by the ability to undertake Activities of Daily Living (ADL) and it has been demonstrated that frailty and the onset of dependence in ADL are strongly associated.
4.2 PRE-CLINICAL DATA/CLINICAL DATA
Cardiac rehabilitation is a complex intervention offered to patients with heart disease and includes components of health education, advice on cardiovascular risk reduction, physical activity and stress management. Cardiac rehabilitation and physical activity are recommended treatments after cardiac valve surgery and positively improves morbidity, exercise capacity and quality of life or emotional well-being. The National Institute for Healthcare Excellence and The Department of Health and wider European guidelines agree that patients who have received heart valve replacements will benefit from cardiac rehabilitation.
4.3 STUDY RATIONALE AND RISK/BENEFIT ANALYSIS
A literature search has not revealed any publications which specifically outline the impact of receiving a programme of cardiac rehabilitation, following TAVR and this study aims to address that question. The ethical dilemma of conducting research in elderly patients who have undergone TAVR can be associated with clinical trials in other elderly populations. The dilemma consists of the need to develop new and better treatment options for a particular group of patients whilst protecting the patient from harm. We anticipate that this study will allow us to understand the feasibility of undertaking this study in a group of patients who have agreed to participate in a research study prior to the TAVR procedure. The pilot study will help us to understand the logistics of providing a cardiac rehabilitation programme for patients and the data we generate will allow us to understand if there are any benefits related to functional, independence, frailty and emotional domains for this patient group. The outcomes from this pilot study may allow us to plan future studies with the aim of developing appropriate guidelines related to the provision of cardiac rehabilitation for this patient group.
4.4 MANAGEMENT OF POTENTIAL STUDY RISKS
Patients who are eligible for TAVR, as determined by the multi-disciplinary team, will be seen in the out-patient clinic or in-patient area by the Research Nurse Manager or delegated research nurse. Full informed consent will be obtained before any research intervention is undertaken. Functional, independence, frailty and emotional assessment will include 6 minute walk teat, 4m gait speed walk, hand grip strength, questionnaires and cognitive assessment.
Patients will undergo TAVR as per routine practice and they will be discharged when safe to do so. The research nurse team will collect clinical data during the admission. All patients will attend clinic for review at 4 weeks post implant, research consent will be reaffirmed and the patients will be randomised to receive a cardiac rehabilitation programme or standard of care.
A personalised programme of cardiac rehabilitation will be developed by expert physiotherapists. Patients in the cardiac rehab group will be assessed for the cardiac rehabilitation prior to any intervention taking place. Patients are monitored during exercise and full emergency equipment is available should there be an emergency.
Patients who are in the standard of care group will have access to the TAVR nurse specialist as well as the designated Consultant and research nurse team to ask any advice at any time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Other: Cardiac RehabilitationPatients will return to the out-patient clinic at 4 weeks post - TAVR and research consent will be re-affirmed. Patients will be randomised to receive a programme of cardiac rehabilitation or routine care at this point. Patients randomised to receive cardiac rehabilitation will meet the cardiac rehab team and undergo baseline assessment for the programme. This involves recording height, weight, blood pressure, oxygen saturation and heart rate and rhythm. An individualised programme will be established to meet the needs of each patient. The patients will undergo a 6 week programme of cardiac rehab. Patients who are not allocated to the intervention group will not receive a cardiac programme and will have access to the TAVR nurse specialist team as would be usual care. |
| Standard of care | No intervention | –15 patients will be randomised to receive a programme of cardiac rehabilitation, and 15 patients will receive standard of care which does not include a routine rehabilitation programme. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Severe symptomatic aortic stenosis accepted for Trans Catheter Aortic Valve Replacement
- Age ≥75 years;
- Participant able and willing to give written informed consent;
- Participant able (in the Investigator's opinion) and willing to comply with all study requirements.
Key exclusion criteria (5 listed)
- Subjects may not enter the study if ANY of the following apply:
- Intervention deemed inappropriate due to co-morbidity or frailty;
- Life expectancy less than one year due to co-morbidity;
- Previous AVR or TAVI;
- Predominant aortic regurgitation (AR).
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 |
|---|---|---|
| Cardiac Rehabilitation | Other | Cardiac Rehabilitation |
Primary outcome
Proportion of patients willing to undertake cardiac rehabilitation following TAVR.
Time frame: 6 months
3 secondary outcomes
Functional capacity by 4 metre gait speed.
Time frame: 6 months
Frailty assessment via the FRIED criteria.
Time frame: 6 months
Hospital Anxiety and Depression score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 18848134Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 21969017Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.
- Derived from this study: PubMed 30564436Rogers P, Al-Aidrous S, Banya W, Haley SR, Mittal T, Kabir T, Panoulas V, Raja S, Bhudia S, Probert H, Prendergast C, Spence MS, Davies S, Moat N, Taylor RS, Dalby M. Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group. Pilot Feasibility Stud. 2018 Dec 13;4:185. doi: 10.1186/s40814-018-0363-8. eCollection 2018.
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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. 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 Cardiac Rehabilitation in people with Aortic Stenosis, run by Royal Brompton & Harefield 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 5 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: finished, as of the sponsor's last update on 9 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (time frame: 6 months). 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 NCT02921880, which also lists 4 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 9 Nov 2017.