Pulmonary Capillary Recruitment in Fontan Patients | NCT04292483

Studies
Pulmonary Capillary Recruitment in Fontan Patients

NCT04292483

Sponsor

Jewish General Hospital

Status

Unknown status

Last Update Posted

Apr 7, 2022Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Nitric Oxide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 29, 2020

First Submission Date that Met QC Criteria

Feb 29, 2020

First Posted Date

Mar 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Apr 7, 2022Actual

Name	Class
National and Kapodistrian University of Athens	OTHER
Tel Aviv University	OTHER
Old Dominion University	OTHER

Description Module

Brief Summary

This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of 3H-benzoyl-Phe-Ala-Pro (BPAP). FCSA will be related to flow and other hemodynamic parameters in order to determine if there is capillary recruitment or distention in Fontan patients. We will also compare baseline FCSA measurements with previously studied normal subjects, to assess the difference in hemodynamic pulmonary functional parameters between these single ventricle physiology patients and normal subjects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Nitric Oxide	Drug	Inhaled vasodilator to increase pulmonary capillary perfusion

Measure	Description	Time Frame
Functional capillary surface area	Measurement of functional capillary surface area pre and post inhaled nitric oxide	30 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fontan failures will be defined as patients with single ventricle physiology and TCPC with clinical signs of dysfunction defined as any of the following:

Decreased functional class WHO/NYHA II or more and clinical signs of congestion (ascites, peripheral edema, increased JVP) and/or NT-proBNP > 399 pg/ml based on [17].
Age > 18 years
Known Fontan's increased pressures a. Fontan mean pressure of ≥15 mmHg and/or transpulmonary gradient ≥ 5 mmHg. b. Pulmonary vascular resistance ≥ 2 woods units. And/or supporting evidence of end-organ damage

1. Clinical or paraclinical evidence of liver congestion and/or fibrosis

a. Evidence in ultrasound or other imaging techniques of liver congestion and/or changes related to cardiac cirrhosis.

b. Fibroscan with grade 2 or + 2. Paraclinical signs of portal hypertension defined as 2 or more:

Thrombocytopenia defined as platelet count < 150.0000
Leukocytopenia defined as white blood cell less than 4.500
Esophageal varices on esophagoduodenoscopy.
Splenomegaly on imaging -

Exclusion Criteria:

Presence of fenestration - the shunts include veno-veno collaterals
Significant anemia defined as Hgb < 120 mg/dl
Pregnancy at the moment of the procedure.
Taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
Usage of nitrates, phosphodiesterase inhibitors or calcium blockers within 3 months of the study.

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Subjects with Fontan failure as described above

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
David Langleben, MD	Contact	5143407531		david.langleben@mcgill.ca
Judith Therrien, MD	Contact	514-340-8232		judith.therrien@mcgill.ca

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides