Aortic StenosisHBCR-TAVRNCT04166682
Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
A study testing Home-based cardiac rehabilitation and Routine care in people with Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Home-based cardiac rehabilitation and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2020to 31 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aortic stenosis accepted for TAVR
- Participant able and willing to give written informed consent
- Participant able (in the investigator's opinion) and willing to comply with all study requirements
- Exclusion Criteria: 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 surgical aortic valve replacement (sAVR) or TAVR
- Predominant aortic regurgitation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of zhejiang university, school of medicine
Hangzhou, Zhejiang, 310000
Xiaoya Wang, Doctor, 15715702712, wxyonce@zju.edu.cn
About this study
Official title: A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
- Conditions
- Aortic Stenosis
- Being tested
- Home-based cardiac rehabilitation, Routine care
- 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.
Home-based cardiac rehabilitationBehavioural
cardiac rehabilitation done at home
Routine careBehavioural
Routine care and followup
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Routine care Receives: Behavioral: Routine care |
| Interventional Group | Experimental | Home-based cardiac rehabilitation Receives: Behavioral: Home-based cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
The total distance walked in meters during 6 minutes.
Measured: 6 weeks
Secondary outcomes (8)
Number of participants die
Number of participants die during the study due to cardiovascular or non-cardiovascular causes.
Measured: 6 weeks, 12 months
Number of participants rehospitalized
Number of participants rehospitalized during the study.
Measured: 6 weeks, 12 months
Number of participants completing home-based cardiac rehabilitation
Number of participants completing home-based cardiac rehabilitation
Measured: 6 weeks
Cardiac function
Ejection fraction estimated by echocardiography
Measured: 12 months
Aortic valve function
Aortic valve function estimated by echocardiography
Measured: 12 months
Number of participants injured
Number of participants injured or die during the course of home-based cardiac rehabilitation
Measured: 6 weeks
Time spent performing activities
Number of minutes in a typical week that participants spent performing activities
Measured: 6 weeks, 12 months
6-minute walk test
The total distance walked in meters during 6 minutes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start9 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianbao Liu, Doctor, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166682
- Sponsor's protocol ID
- ZJUWXY
- Acronym
- HBCR-TAVR
- Status last verified
- Jul 2019
- First submitted
- 26 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PubMed 33962483
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT04166682
- Acronym / sponsor ID
- HBCR-TAVR / ZJUWXY
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Nov 2019 (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.
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Routine careRoutine care |
| Interventional Group | Experimental | Behavioral: Home-based cardiac rehabilitationHome-based cardiac rehabilitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Aortic stenosis accepted for TAVR
- Participant able and willing to give written informed consent
- Participant able (in the investigator's opinion) and willing to comply with all study requirements
- Exclusion Criteria: subjects may not enter the study if any of the following apply
- Intervention deemed inappropriate due to co-morbidity or frailty
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home-based cardiac rehabilitationcardiac rehabilitation done at home | Behavioural | Interventional Group |
| Routine careRoutine care and followup | Behavioural | Control Group |
Primary outcome
6-minute walk test
Time frame: 6 weeks
The total distance walked in meters during 6 minutes.
8 secondary outcomes
Number of participants die
Time frame: 6 weeks, 12 months
Number of participants rehospitalized
Time frame: 6 weeks, 12 months
Number of participants completing home-based cardiac rehabilitation
Time frame: 6 weeks
Cardiac function
Time frame: 12 months
Aortic valve function
Time frame: 12 months
Number of participants injured
Time frame: 6 weeks
Time spent performing activities
Time frame: 6 weeks, 12 months
6-minute walk test
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 33962483Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
- Individual participant dataSharing planned: No
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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.
Xianbao Liu, Doctor study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based cardiac rehabilitation and Routine care in people with Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 May 2020. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoya Wang, Doctor (+86-15715702712, wxyonce@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 6 weeks). 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 NCT04166682, which also lists 1 linked publication.
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 12 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.