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

May 6, 2021 updated by: Philipp Lurz, Heart Center Leipzig - University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center of the University Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of RV diastolic dysfunction in CHD and RVOT dysfunction
Time Frame: Baseline
Determination of load-independent stiffness constant in CHD
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Link between RV load-independent stiffness constant and functional capacity
Time Frame: Baseline
Oxygen uptake (VO2 max) in correlation to load-independent stiffness constant
Baseline
Association between E/É and RV stiffness in CHD
Time Frame: Baseline
Correlation between E/É and load-independent stiffness constant
Baseline
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Center Leipzig - University Hospital

Investigators

  • Principal Investigator: Ingo Dähnert, MD, Head of pediatric cardiology, Heart Center Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2016

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADICAL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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