Pulmonary Capillary Recruitment in Fontan Patients

Sponsor

Jewish General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04292483

Collaborator

National and Kapodistrian University of Athens (Other), Tel Aviv University (Other), Old Dominion University (Other)

Enrollment

Location

42.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Drug: Nitric Oxide

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection.

Actual Study Start Date :

Jun 11, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Functional capillary surface area [30 minutes]
Measurement of functional capillary surface area pre and post inhaled nitric oxide

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Clinical or paraclinical evidence of liver congestion and/or fibrosis

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

Jewish General Hospital
National and Kapodistrian University of Athens
Tel Aviv University
Old Dominion University

Investigators

Principal Investigator: David Langleben, MD, Jewish General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr David Langleben, Professor of Medicine (Cardiology), Jewish General Hospital

ClinicalTrials.gov Identifier:

NCT04292483

Other Study ID Numbers:

1900-5, 00-034

First Posted:

Mar 3, 2020

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Nitric Oxide

Study Results

No Results Posted as of Apr 7, 2022