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Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease (RaDICAL-CHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471936
Recruitment Status : Active, not recruiting
First Posted : March 21, 2018
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, Heart Center Leipzig - University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Regurgitation Congenital Heart Disease Diagnostic Test: Acquisition of pressure-volume-loops Not Applicable

Detailed Description:

One of the major problems in the expanding population of patients with congenital heart disease (CHD) is dysfunction of the right ventricular (RV) outflow tract (OT). Initial surgical repair for complex conditions or repeated surgery for free pulmonary regurgitation often includes the creation of an artificial RV to main pulmonary artery connection. Over time, these conduits are prone to develop valvar incompetence or obstruction. There is clear evidence that pulmonary stenosis and pulmonary regurgitation are associated with exercise intolerance, arrhythmias and an increased risk of sudden death. Timely pulmonary valve replacement can halt and may reverse such unfavourable outcomes. However, this means that patients have to undergo multiple open-heart surgeries in order to reduce the haemodynamic burden on the right ventricle. Decision making in these patients with RVOT dysfunction is based on the aim to perform pulmonary valve replacement as late as possible to minimise the total number of open-heart surgeries required in individual patients, but before functional impairment might be irreversible. Importantly, this point of 'no return' in right ventricular pressure and/or volume overload is still unknown and represents one of the most challenging problems in the field of CHD. Ideally, quality of life, survival and freedom from atrial and ventricular arrhythmia should be the endpoints for any study trying to optimise timing of pulmonary valve replacement. However, such studies would require long follow-up in large patient populations and will not help to improve management of right ventricular outflow tract (RVOT) dysfunction in the short-term. In order to design studies with surrogate functional endpoints, a sound understanding of physiological consequences of altering RV loading and its implications for bi-ventricular function or exercise capacity is pivotal.

The investigators established a method of acquiring robust RV pressure-volume-loops at our institution. In the context of a research study, the investigators performed RV conductance catheter measurements in 22 patients with heart failure with preserved ejection fraction and in 11 patients with no evidence of any RV disease. Within the RaDICAL study the investigators aim further to compare these results to pressure-volume loops acquired in patients with congenital heart disease (CHD) and adverse RV loading conditions in order to evaluate characteristics, incidence and predictors of load-independent right ventricle (RV) diastolic dysfunction.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease
Actual Study Start Date : July 7, 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Acquisition of pressure-volume loops Diagnostic Test: Acquisition of pressure-volume-loops
Diagnostic workup including cardiac MRI, Echocardiography and cardiopulmonary exercise test (CPET) followed by invasive acquisition of RV and left ventricular (LV) pressure-volume-loops


Outcome Measures
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Primary Outcome Measures :
  1. Presence of RV diastolic dysfunction in CHD and RVOT dysfunction [ Time Frame: Baseline ]
    Determination of load-independent stiffness constant in CHD


Secondary Outcome Measures :
  1. Link between RV load-independent stiffness constant and functional capacity [ Time Frame: Baseline ]
    Oxygen uptake (VO2 max) in correlation to load-independent stiffness constant

  2. Association between E/É and RV stiffness in CHD [ Time Frame: Baseline ]
    Correlation between E/É and load-independent stiffness constant

  3. Association between RV stiffness expressed as E/É and functional outcome after surgical or percutaneous pulmonary valve replacement [ Time Frame: 6 months ]
    Correlation between E/É before intervention and VO2 max change after pulmonary valve replacement


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindication for magnetic resonance imaging or cardiopulmonary exercise testing
  • Pregnancy
  • RV systolic function on magnetic resonance imaging < 45%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471936


Locations
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Germany
Heart Center of the University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
Heart Center Leipzig - University Hospital
Investigators
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Principal Investigator: Ingo Dähnert, MD Head of pediatric cardiology, Heart Center Leipzig
More Information
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Publications:

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Responsible Party: Philipp Lurz, Clinical Investigator M.D. Ph. D. Philipp Lurz, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT03471936    
Other Study ID Numbers: RADICAL001
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Philipp Lurz, Heart Center Leipzig - University Hospital:
Congenital Heart Disease
pressure-volume loops
diastolic function
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Diseases
Heart Defects, Congenital
Pulmonary Valve Insufficiency
Cardiovascular Diseases
 Cardiovascular Abnormalities
Congenital Abnormalities
Heart Valve Diseases
Respiration Disorders
Respiratory Tract Diseases