Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease

NCT03471936 | Unknown FDA Device

• 1 other identifier: RADICAL001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the characteristics, incidence and predictors of load-independent right ventricle (RV) diastolic dysfunction in patients with congenital heart disease (CHD) and adverse RV loading conditions by acquiring pressure-volume loops and compare these results to a population of patients with exclusion of coronary artery disease and absence of any known disease affecting the RV.

Conditions

Pulmonary Regurgitation; Congenital Heart Disease

Keywords

Congenital Heart Disease; pressure-volume loops; diastolic function

Outcome Measures

Primary Outcomes (1)

• Presence of RV diastolic dysfunction in CHD and RVOT dysfunction

  Determination of load-independent stiffness constant in CHD

  Baseline

Secondary Outcomes (3)

• Link between RV load-independent stiffness constant and functional capacity

  Baseline

• Association between E/É and RV stiffness in CHD

  Baseline

• Association between RV stiffness expressed as E/É and functional outcome after surgical or percutaneous pulmonary valve replacement

  6 months

Study Arms (1)

Acquisition of pressure-volume loops

OTHER

Diagnostic Test: Acquisition of pressure-volume-loops

Interventions

Acquisition of pressure-volume-loops DIAGNOSTIC_TEST

Diagnostic workup including cardiac MRI, Echocardiography and cardiopulmonary exercise test (CPET) followed by invasive acquisition of RV and left ventricular (LV) pressure-volume-loops

Acquisition of pressure-volume loops

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with CHD involving the RV
• Chronic RV volume and/or pressure overload as defined by:
• more than mild pulmonary regurgitation and/or
• more than mild tricuspid regurgitation and/or
• a gradient across the RV outflow tract of ≥ 3 m/s on echocardiography and/or
• estimated RV systolic pressure \> 65 mmHg
• Clinical indication for cardiac catheterization
• Age 12 to 80 years
• Informed consent

You may not qualify if:

• Contraindication for magnetic resonance imaging or cardiopulmonary exercise testing
• Pregnancy
• RV systolic function on magnetic resonance imaging \< 45%

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (1)

Heart Center of the University Leipzig

Leipzig, 04289, Germany

Location

Related Publications (12)

• Brown JW, Ruzmetov M, Rodefeld MD, Vijay P, Turrentine MW. Right ventricular outflow tract reconstruction with an allograft conduit in non-ross patients: risk factors for allograft dysfunction and failure. Ann Thorac Surg. 2005 Aug;80(2):655-63; discussion 663-4. doi: 10.1016/j.athoracsur.2005.02.053.

  PMID: 16039222 BACKGROUND

• Rastan AJ, Walther T, Daehnert I, Hambsch J, Mohr FW, Janousek J, Kostelka M. Bovine jugular vein conduit for right ventricular outflow tract reconstruction: evaluation of risk factors for mid-term outcome. Ann Thorac Surg. 2006 Oct;82(4):1308-15. doi: 10.1016/j.athoracsur.2006.04.071.

  PMID: 16996925 BACKGROUND

• Stark J, Bull C, Stajevic M, Jothi M, Elliott M, de Leval M. Fate of subpulmonary homograft conduits: determinants of late homograft failure. J Thorac Cardiovasc Surg. 1998 Mar;115(3):506-14; discussion 514-6. doi: 10.1016/S0022-5223(98)70312-5.

  PMID: 9535436 BACKGROUND

• Tweddell JS, Pelech AN, Frommelt PC, Mussatto KA, Wyman JD, Fedderly RT, Berger S, Frommelt MA, Lewis DA, Friedberg DZ, Thomas JP Jr, Sachdeva R, Litwin SB. Factors affecting longevity of homograft valves used in right ventricular outflow tract reconstruction for congenital heart disease. Circulation. 2000 Nov 7;102(19 Suppl 3):III130-5. doi: 10.1161/01.cir.102.suppl_3.iii-130.

  PMID: 11082375 BACKGROUND

• Gatzoulis MA, Balaji S, Webber SA, Siu SC, Hokanson JS, Poile C, Rosenthal M, Nakazawa M, Moller JH, Gillette PC, Webb GD, Redington AN. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet. 2000 Sep 16;356(9234):975-81. doi: 10.1016/S0140-6736(00)02714-8.

  PMID: 11041398 BACKGROUND

• Carvalho JS, Shinebourne EA, Busst C, Rigby ML, Redington AN. Exercise capacity after complete repair of tetralogy of Fallot: deleterious effects of residual pulmonary regurgitation. Br Heart J. 1992 Jun;67(6):470-3. doi: 10.1136/hrt.67.6.470.

  PMID: 1622697 BACKGROUND

• Lurz P, Puranik R, Nordmeyer J, Muthurangu V, Hansen MS, Schievano S, Marek J, Bonhoeffer P, Taylor AM. Improvement in left ventricular filling properties after relief of right ventricle to pulmonary artery conduit obstruction: contribution of septal motion and interventricular mechanical delay. Eur Heart J. 2009 Sep;30(18):2266-74. doi: 10.1093/eurheartj/ehp258. Epub 2009 Jun 26.

  PMID: 19561027 BACKGROUND

• Lurz P, Riede FT, Taylor AM, Wagner R, Nordmeyer J, Khambadkone S, Kinzel P, Derrick G, Schuler G, Bonhoeffer P, Giardini A, Daehnert I. Impact of percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction on exercise recovery kinetics. Int J Cardiol. 2014 Nov 15;177(1):276-80. doi: 10.1016/j.ijcard.2014.09.014. Epub 2014 Sep 22.

  PMID: 25499392 BACKGROUND

• Lurz P, Nordmeyer J, Muthurangu V, Khambadkone S, Derrick G, Yates R, Sury M, Bonhoeffer P, Taylor AM. Comparison of bare metal stenting and percutaneous pulmonary valve implantation for treatment of right ventricular outflow tract obstruction: use of an x-ray/magnetic resonance hybrid laboratory for acute physiological assessment. Circulation. 2009 Jun 16;119(23):2995-3001. doi: 10.1161/CIRCULATIONAHA.108.836312. Epub 2009 Jun 1.

  PMID: 19487596 BACKGROUND

• Lurz P, Coats L, Khambadkone S, Nordmeyer J, Boudjemline Y, Schievano S, Muthurangu V, Lee TY, Parenzan G, Derrick G, Cullen S, Walker F, Tsang V, Deanfield J, Taylor AM, Bonhoeffer P. Percutaneous pulmonary valve implantation: impact of evolving technology and learning curve on clinical outcome. Circulation. 2008 Apr 15;117(15):1964-72. doi: 10.1161/CIRCULATIONAHA.107.735779. Epub 2008 Apr 7.

  PMID: 18391109 BACKGROUND

• Burkhoff D, Mirsky I, Suga H. Assessment of systolic and diastolic ventricular properties via pressure-volume analysis: a guide for clinical, translational, and basic researchers. Am J Physiol Heart Circ Physiol. 2005 Aug;289(2):H501-12. doi: 10.1152/ajpheart.00138.2005.

  PMID: 16014610 BACKGROUND

• Dimopoulos K, Okonko DO, Diller GP, Broberg CS, Salukhe TV, Babu-Narayan SV, Li W, Uebing A, Bayne S, Wensel R, Piepoli MF, Poole-Wilson PA, Francis DP, Gatzoulis MA. Abnormal ventilatory response to exercise in adults with congenital heart disease relates to cyanosis and predicts survival. Circulation. 2006 Jun 20;113(24):2796-802. doi: 10.1161/CIRCULATIONAHA.105.594218. Epub 2006 Jun 12.

  PMID: 16769913 BACKGROUND

MeSH Terms

Conditions

Pulmonary Valve Insufficiency; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ingo Dähnert, MD

  Head of pediatric cardiology, Heart Center Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator M.D. Ph. D. Philipp Lurz

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 21, 2018
• Study Start: July 7, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)