Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis (RECOVERY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Asan Medical Center
Sponsor:
Collaborator:
Korea Institute of Medicine
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01161732
First received: July 12, 2010
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.


Condition Intervention Phase
Aortic Stenosis
Procedure: Early surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Cardiac mortality [ Time Frame: Entire follow-up ( a minimum of 4 years) ] [ Designated as safety issue: No ]
    defined as death from complications of myocardial infarction, heart failure, shock, complications of cardiac surgery or intervention, other cardiovascular diseases including sudden cardiac death

  • Operative mortality [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    Operative mortality is defined as death within 30 days of surgery.


Secondary Outcome Measures:
  • All-cause death [ Time Frame: Entire follow-up (a minimum of 4 years) ] [ Designated as safety issue: No ]
  • Repeat aortic valve surgery [ Time Frame: Entire follow-up (a minimum of 4 years) ] [ Designated as safety issue: Yes ]
  • Clinical thromboembolic events [ Time Frame: Entire follow-up (a minimum of 4 years) ] [ Designated as safety issue: Yes ]
    Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.

  • Hospitalization due to congestive heart failure [ Time Frame: Entire follow-up (a minimum of 4 years) ] [ Designated as safety issue: No ]
    A hospitalization due to congestive heart failure is defined as an unplanned, urgent admission for the management of congestive heart failure.


Estimated Enrollment: 144
Study Start Date: April 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional treatment
In the conventional treatment group, indications for aortic valve replacement surgery are development of symptoms, reduced left ventricular systolic function and an increase in aortic jet velocity > 0.5 m/sec during follow-up.
Active Comparator: Early Surgery
Early surgery is performed within 2 months of randomization.
Procedure: Early surgery
Early surgery is performed within 2 months of randomization.
Other Name: Early aortic valve replacement surgery

Detailed Description:

Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated AV replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College of Cardiology/American Heart Association guidelines recommend surgery as a class IIb indication only in patients with extremely severe AS and who are at low operative risk. Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and asymptomatic patients with very severe AS are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe AS, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe AS is associated with an improved long-term survival in a prospective, observational study. However, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe AS. We sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.

According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.

Exclusion Criteria:

  • Exertional dyspnea
  • Angina
  • Syncope
  • Left ventricular ejection fraction < 50%
  • Significant aortic regurgitation
  • Significant mitral valve disease
  • Pregnancy
  • Age < 20 years or > 80 years
  • Coexisting malignancies
  • Positive exercise test
  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: NCT01161732

Contacts
Contact: Duk-Hyun Kang, M.D. 82-2-3010-3166 dhkang@amc.seoul.kr
Contact: Dae-Hee Kim, M.D. 82-2-3010-3151 daehee74@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Duk-Hyun Kang, M.D.    82-2-3010-3166    dhkang@amc.seoul.kr   
Contact: Dae-Hee Kim, M.D.    82-2-3010-3151    daehee74@amc.seoul.kr   
Principal Investigator: Duk-Hyun Kang, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Seung Woo Park, M.D.       parksmc@gmail.com   
Contact: Sung-Ji Park, M.D,       sungji.park@samsung.com   
Principal Investigator: Seung Woo Park, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong-Jin Kim, MD, PhD       kimdamas@snu.ac.kr   
Principal Investigator: Yong-Jin Kim, MD,PhD         
Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Geu-Ru Hong, MD, PhD    822-2228-8226    grhong@yuhs.ac   
Principal Investigator: Geu-Ru Hong, MD, PhD         
Sponsors and Collaborators
Asan Medical Center
Korea Institute of Medicine
Investigators
Principal Investigator: Duk-Hyun Kang, M.D. Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Duk-Hyun Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01161732     History of Changes
Other Study ID Numbers: 2010-0065
Study First Received: July 12, 2010
Last Updated: May 8, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
aortic stenosis
surgery, survival

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014