Pulmonary Capillary Recruitment in Fontan Patients

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292483
• Other study ID #: 1900-5, 00-034
• Status: Recruiting
• Start date: June 11, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Jewish General Hospital
• Contact: David Langleben, MD
• Phone: 5143407531
• Email: david.langleben[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

1. 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].

2. Age > 18 years

3. 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:

1. Thrombocytopenia defined as platelet count < 150.0000

2. Leukocytopenia defined as white blood cell less than 4.500

3. Esophageal varices on esophagoduodenoscopy.

4. Splenomegaly on imaging -

Exclusion Criteria:

1. Presence of fenestration - the shunts include veno-veno collaterals

2. Significant anemia defined as Hgb < 120 mg/dl

3. Pregnancy at the moment of the procedure.

4. Taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.

5. Usage of nitrates, phosphodiesterase inhibitors or calcium blockers within 3 months of the study.

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Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• Nitric Oxide
Inhaled vasodilator to increase pulmonary capillary perfusion

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Jewish General Hospital	National and Kapodistrian University of Athens, Old Dominion University, Tel Aviv University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capillary surface area	Measurement of functional capillary surface area pre and post inhaled nitric oxide	30 minutes