Novel Cardiac Imaging Prognostic Markers of Clinical Outcome in Patients With Chronic Aortic Regurgitation

NCT02910349 | Completed DMC

• 1 other identifier: 00023001
• Study Type: observational
• Target: 129
• Locations: 2 countries
• Sites: 5

Brief Summary

Severe aortic regurgitation is a common valvular heart disease with prevalence of approximately 1%, affecting rather younger patients. The surgical treatment is the only causal treatment; it is recommended in patients with severe symptomatic aortic regurgitation. The optimal timing of the surgery is crucial because there is a certain risk of perioperative mortality and most patients require lifelong anticoagulation therapy. It is widely accepted, that asymptomatic patients with severely dilated left ventricle with systolic impairment have worse postoperative prognosis. We aim to evaluate native myocardial T1 relaxation time derived from cardiac magnetic resonance and global longitudinal left ventricular strain measured by echocardiography. These parameters are related to diffuse myocardial fibrosis and we expect to identify the cut off values, which correlate with further clinical course. This might enable better timing of the surgical treatment with the optimal postoperative left ventricular reverse remodelling and improved patient prognosis.

Conditions

Aortic Valve Disorder

Keywords

valvular hear disease; echocardiography; magnetic resonance; global longitudinal strain; T1 relaxation time

Outcome Measures

Primary Outcomes (9)

• Indication for aortic regurgitation surgical correction

  number of participants undergoing valve surgery

  within 7 years of follow-up

• Echocardiography (ECHO) - left ventricular (LV) end-systolic diameter (ESD) > 50 mm

  all participants

  each visit (6 months) within 7 years

• Echocardiography (ECHO) - left ventricular ejection fraction (LV EF) < 50 % finding

  all participants

  each visit (6 months) within 7 years

• Clinical symptoms occurrence such as dyspnoea class I (New York Heart Association (NYHA)

  all participants

  within 7 years of follow-up

• Arrhythmia (non-sustained or sustained ventricular tachycardia, ventricular ectopic beats > 10%, atrial fibrillation)

  all participants

  within 7 years of follow-up

• Hospitalization for heart failure symptoms

  all participants

  within 7 years of follow-up

• Laboratory findings: Brain natriuretic peptide (BNP) elevation > 150 ng/L

  all participants

  within 7 years of follow-up

• Cardiovascular death

  all participants

  within 7 years of follow-up

• Cumulative endpoint of all the above

  all participants

  within 7 years of follow-up

Secondary Outcomes (6)

• Echocardiography (ECHO) - Increase of left ventricular (LV) end-systolic diameter of > 10 mm in an individual patient without surgery

  within 7 years

• Echocardiography (ECHO) - Increase of left ventricular (LV) end-diastolic diameter of > 15 mm in an individual patient without surgery

  within 7 years

• Echocardiography (ECHO) - Decrease of global longitudinal strain (GLS) of > 5 % in an individual patient without surgery

  within 7 years

• Echocardiography (ECHO) - Increase of left ventricular (LV) mass index of > 10 % in an individual patient without surgery

  within 7 years

• Echocardiography (ECHO) - Postoperative reduction of left ventricular (LV) end-diastolic diameter of > 10 mm in an individual patient

  in patients undergoing valve surgery 3-12 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with grade 3 to 4 aortic regurgitation

You may qualify if:

• Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)
• No indication for the surgical treatment at the time of enrolment
• LV EF ≥ 50 %
• Absence of more than mild concomitant valve disease or complex congenital heart disease

You may not qualify if:

• Age \< 18 years
• Clearance Creatinine \< 30 mL/min
• Contraindication of magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, aneurysm clip, metallic fragment in the eye or near sensitive tissue)
• Pregnancy

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead
• Faculty Hospital Kralovske Vinohrady: collaborator
• General University Hospital, Prague: collaborator
• VZW Cardiovascular Research Center Aalst: collaborator
• University Hospital Hradec Kralove: collaborator

Study Sites (5)

VZW Cardiovascular Research Center Aalst

Aalst, Belgium

Location

Karel Medilek, M.D.

Hradec Králové, 50005, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, 14000, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

Location

General University Hospital

Prague, Czechia

Location

Related Publications (11)

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 BACKGROUND

• Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2013 Mar;14(3):167-214. doi: 10.1714/1234.13659. No abstract available. Italian.

  PMID: 23474606 BACKGROUND

• Aicher D, Fries R, Rodionycheva S, Schmidt K, Langer F, Schafers HJ. Aortic valve repair leads to a low incidence of valve-related complications. Eur J Cardiothorac Surg. 2010 Jan;37(1):127-32. doi: 10.1016/j.ejcts.2009.06.021. Epub 2009 Jul 29.

  PMID: 19643618 BACKGROUND

• Smedsrud MK, Pettersen E, Gjesdal O, Svennevig JL, Andersen K, Ihlen H, Edvardsen T. Detection of left ventricular dysfunction by global longitudinal systolic strain in patients with chronic aortic regurgitation. J Am Soc Echocardiogr. 2011 Nov;24(11):1253-9. doi: 10.1016/j.echo.2011.08.003. Epub 2011 Sep 10.

  PMID: 21908174 BACKGROUND

• Chaliki HP, Mohty D, Avierinos JF, Scott CG, Schaff HV, Tajik AJ, Enriquez-Sarano M. Outcomes after aortic valve replacement in patients with severe aortic regurgitation and markedly reduced left ventricular function. Circulation. 2002 Nov 19;106(21):2687-93. doi: 10.1161/01.cir.0000038498.59829.38.

  PMID: 12438294 BACKGROUND

• Messroghli DR, Radjenovic A, Kozerke S, Higgins DM, Sivananthan MU, Ridgway JP. Modified Look-Locker inversion recovery (MOLLI) for high-resolution T1 mapping of the heart. Magn Reson Med. 2004 Jul;52(1):141-6. doi: 10.1002/mrm.20110.

  PMID: 15236377 BACKGROUND

• Mewton N, Liu CY, Croisille P, Bluemke D, Lima JA. Assessment of myocardial fibrosis with cardiovascular magnetic resonance. J Am Coll Cardiol. 2011 Feb 22;57(8):891-903. doi: 10.1016/j.jacc.2010.11.013.

  PMID: 21329834 BACKGROUND

• Reant P, Barbot L, Touche C, Dijos M, Arsac F, Pillois X, Landelle M, Roudaut R, Lafitte S. Evaluation of global left ventricular systolic function using three-dimensional echocardiography speckle-tracking strain parameters. J Am Soc Echocardiogr. 2012 Jan;25(1):68-79. doi: 10.1016/j.echo.2011.10.009. Epub 2011 Nov 13.

  PMID: 22082980 BACKGROUND

• Russo C, Jin Z, Elkind MS, Rundek T, Homma S, Sacco RL, Di Tullio MR. Prevalence and prognostic value of subclinical left ventricular systolic dysfunction by global longitudinal strain in a community-based cohort. Eur J Heart Fail. 2014 Dec;16(12):1301-9. doi: 10.1002/ejhf.154. Epub 2014 Sep 11.

  PMID: 25211239 BACKGROUND

• Kockova R, Kacer P, Pirk J, Maly J, Sukupova L, Sikula V, Kotrc M, Barciakova L, Honsova E, Maly M, Kautzner J, Sedmera D, Penicka M. Native T1 Relaxation Time and Extracellular Volume Fraction as Accurate Markers of Diffuse Myocardial Fibrosis in Heart Valve Disease - Comparison With Targeted Left Ventricular Myocardial Biopsy. Circ J. 2016 Apr 25;80(5):1202-9. doi: 10.1253/circj.CJ-15-1309. Epub 2016 Mar 17.

  PMID: 26984717 BACKGROUND

• Kockova R, Linkova H, Hlubocka Z, Medilek K, Tuna M, Vojacek J, Skalsky I, Cerny S, Maly J, Hlubocky J, Mizukami T, De Colle C, Penicka M. Multiparametric Strategy to Predict Early Disease Decompensation in Asymptomatic Severe Aortic Regurgitation. Circ Cardiovasc Imaging. 2022 Dec;15(12):e014901. doi: 10.1161/CIRCIMAGING.122.014901. Epub 2022 Dec 20.

  PMID: 36538596 DERIVED

Related Links

• V1.4 MRmap software

Biospecimen

Retention: SAMPLES WITH DNA

Myocardial biopsy specimen

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Radka Kockova, MD, PhD

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

• Ales Linhart, Prof,MD,PhD

  General University Hospital

  STUDY DIRECTOR

• Hana Linkova, MD, PhD

  Faculty Hospital Kralovske Vinohrady

  STUDY DIRECTOR

• Martin Penicka

  VZW Cardiovascular Research Center Aalst

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Radka Kockova MD, PhD

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); CZ (4)