Clinical trial NCT04056832: Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Official title: Left Ventricular Reverse Remodeling in Aortic Valve Replacement With Single Strip Pericardium and Mechanical Valve: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Stenosis
Valve Stenoses, Aortic
Aortic Valve Calcification
Keywords: Aortic Stenosis
Aortic Valve Replacement
Single Strip Pericardium
Autologous Pericardium
Mechanical Valve Replacement
Comparison of Left Ventricle Remodeling
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 62
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. In addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from Ozaki et al and Duran et al.

The objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis.

This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is having low to moderate surgical risk (EuroScore II \<5). The sampling method used in this study is non-probability consecutive sampling. This study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2, 6MWT) at 3 months and 6 months post-aortic valve replacement.

It is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Patients aged more than 10 years old
* Patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (EuroScore II \<5)
* The patient or guardian (the research subject's parent) agrees to follow the study

Exclusion Criteria:

* Patients who have previously underwent aortic valve replacement
* Patients with aortic stenosis due to bicuspid aortic valve
* Patients with autoimmune disease
* Patients with mixed connective tissue disease

Primary outcomes:
measure: Change in Left Ventricular End Diastolic Diameter
timeFrame: before surgery, 3 months and 6 months after surgery
measure: Change in Left Ventricular End Systolic Diameter
timeFrame: before surgery, 3 months and 6 months after surgery
measure: Change in Ejection Fraction Percentage
timeFrame: before surgery, 3 months and 6 months after surgery
measure: Change in 6 Minute Walking Test Performance (meters)
timeFrame: before surgery, 3 months and 6 months after surgery
measure: Change in 6 Minute Walking Test Performance (METs)
timeFrame: before surgery, 3 months and 6 months after surgery
measure: Change in Soluble Suppression of Tumorigenicity-2 (sST2) Level
timeFrame: before surgery, 3 months and 6 months after surgery
Secondary outcomes:
measure: Coaptation Height of Aortic Valve Leaflet in mili meters
timeFrame: at the time of surgery
measure: Effective Height of Aortic Valve in mili meters
timeFrame: at the time of surgery
measure: Aortic Jet Velocity Value in m/s
timeFrame: before surgery
measure: Mean Trans-aortic Pressure Gradient Value in mmHg
timeFrame: before surgery
measure: Aortic Stenosis Severity
timeFrame: before surgery
measure: Aortic Regurgitation Severity
timeFrame: before surgery
measure: Number of Valve Replacement and/or Repair
timeFrame: at the time of surgery
measure: Aortic Cross Clamp Time in minute
timeFrame: at the time of surgery
measure: Surgery Time in minute
timeFrame: at the time of surgery
measure: Cardiopulmonary Bypass Time in minute
timeFrame: at the time of surgery
measure: Duration of Hospitalization
timeFrame: at the time of surgery
Other outcomes:
measure: Duration of Intensive Care Unit Stay
timeFrame: at the time of surgery
measure: Duration of Ventilator Use
timeFrame: at the time of surgery
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Ismail Dilawar, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: d'Arcy JL, Prendergast BD, Chambers JB, Ray SG, Bridgewater B. Valvular heart disease: the next cardiac epidemic. Heart. 2011 Jan;97(2):91-3. doi: 10.1136/hrt.2010.205096. Epub 2010 Dec 13. No abstract available.
citation: Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
citation: Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.
citation: Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706.