Heart FailureADOPTNCT01018667
Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China
An observational study of Heart Failure, run by Xijing Hospital at 1 site in China.
Trial summary
The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases enrollment. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to CRT group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Dec 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About eight hundred patients will be enrolled in this study at more than 40 centers in the China. To participate in the study, patients must meet the Guideline for cardiac resynchronization therapy in patients with chronic heart failure in China.
Who may be able to join
- Heart failure patients who must meet all criteria:1.ischemic or nonischemic cardiomyopathy;2.NYHA classes III-IV despite OPT;3.normal sinus rhythm;4.LVEF≤35%;5.LV end-diastolic diameter≥55mm;and 6.Wide QRS complex≥120ms.
Who cannot join
- 1.Potentially reversible forms of cardiomyopathy;2.Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction, unstable or severe angina or stroke within 6 weeks before randomization;3.In-patients requiring continuous intravenous therapy for heart failure;4.Life expectancy<1 year for disease unrelated to heart failure;5.Mechanical tricuspid valve;6.Anticipated problem with compliance;7.Participation in another trial;8.Age<18 years old;9.Women who are pregnant or not using medically acceptable birth control.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology,xijing hospital
Xi'an, Shaanxi, 710032
Fu Yi, Dr., 86-029-84775183, yi12fu56@hotmail.com
About this study
Official title: The ADOPT Trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China): Rationale, Design and End-points
The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases enrollment. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group for Selection). After successful match, the cases in Group for Selection enters into follow-up and become control group. The unmatched cases in the Group for Selection will be removed. If patients agree, after re-evaluation of the baseline situation, she or he may enter into Group for Selection again. Since patients know she/he already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is open-label designed, however the executive committee will be kept blind when making event-adjudication. Prospectively defined primary end points for the study include combined all-cause mortality and hospitalizations. A variety of secondary end points will further define the efficacy and mechanism(s) of action of cardiac resynchronization in heart failure. The last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. All cases collection complete in 2010 and study result will be reported in 2012.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, clinical trial, biventricular pacing, cardiac device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRT group | Not described | |
| OPT group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018667
- Sponsor's protocol ID
- Xijing-1
- Acronym
- ADOPT
- Status last verified
- Jun 2010
- First submitted
- 22 Nov 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ADOPT Trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China): Rationale, Design and End-points
- ClinicalTrials.gov ID
- NCT01018667
- Acronym / sponsor ID
- ADOPT / Xijing-1
- Conditions
- Heart Failure
- Keywords
- Heart Failure, clinical trial, biventricular pacing, cardiac device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (estimated)
- First posted
- 25 Nov 2009 (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 ADOPT study is a prospective, nested case-controlled and open label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases enrollment. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group for Selection). After successful match, the cases in Group for Selection enters into follow-up and become control group. The unmatched cases in the Group for Selection will be removed. If patients agree, after re-evaluation of the baseline situation, she or he may enter into Group for Selection again. Since patients know she/he already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is open-label designed, however the executive committee will be kept blind when making event-adjudication. Prospectively defined primary end points for the study include combined all-cause mortality and hospitalizations. A variety of secondary end points will further define the efficacy and mechanism(s) of action of cardiac resynchronization in heart failure. The last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. All cases collection complete in 2010 and study result will be reported in 2012.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT group | – | – |
| OPT group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About eight hundred patients will be enrolled in this study at more than 40 centers in the China. To participate in the study, patients must meet the Guideline for cardiac resynchronization therapy in patients with chronic heart failure in China.
Key inclusion criteria (1 listed)
- Heart failure patients who must meet all criteria:1.ischemic or nonischemic cardiomyopathy;2.NYHA classes III-IV despite OPT;3.normal sinus rhythm;4.LVEF≤35%;5.LV end-diastolic diameter≥55mm;and 6.Wide QRS complex≥120ms.
Key exclusion criteria (1 listed)
- 1.Potentially reversible forms of cardiomyopathy;2.Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction, unstable or severe angina or stroke within 6 weeks before randomization;3.In-patients requiring continuous intravenous therapy for heart failure;4.Life expectancy<1 year for disease unrelated to heart failure;5.Mechanical tricuspid valve;6.Anticipated problem with compliance;7.Participation in another trial;8.Age<18 years old;9.Women who are pregnant or not using medically acceptable birth control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Xijing Hospital 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 1 inclusion and 1 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 23 Jul 2010. 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. 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 Fu Yi, Dr. (86-029-84775183, yi12fu56@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 23 Jul 2010.