Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China (ADOPT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01018667
First received: November 22, 2009
Last updated: July 21, 2010
Last verified: June 2010
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRT group
OPT group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018667

Contacts
Contact: Fu Yi, Dr. 86-029-84775183 yi12fu56@hotmail.com

Locations
China, Shaanxi
Department of Cardiology,xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Fu Yi, Dr.    86-029-84775183    yi12fu56@hotmail.com   
Sponsors and Collaborators
Xijing Hospital
Medtronic
  More Information

No publications provided

Responsible Party: Dr. Wang HC/Department of Cardiology, xijing hospital, Department of Cardiology, xijing hospital
ClinicalTrials.gov Identifier: NCT01018667     History of Changes
Other Study ID Numbers: Xijing-1
Study First Received: November 22, 2009
Last Updated: July 21, 2010
Health Authority: China: Ministry of Health

Keywords provided by Xijing Hospital:
Heart Failure
clinical trial
biventricular pacing
cardiac device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014