Pulmonary Capillary Recruitment in Fontan Patients

NCT04292483 | Unknown

• 1 other identifier: 1900-5, 00-034
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Functional capillary surface area

  Measurement of functional capillary surface area pre and post inhaled nitric oxide

  30 minutes

Interventions

Nitric Oxide DRUG

Inhaled vasodilator to increase pulmonary capillary perfusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects with Fontan failure as described above

You may qualify if:

• 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
• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead
• National and Kapodistrian University of Athens: collaborator
• Tel Aviv University: collaborator
• Old Dominion University: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• David Langleben, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Langleben, MD

CONTACT

5143407531; david.langleben@mcgill.ca

Judith Therrien, MD

CONTACT

514-340-8232; judith.therrien@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology)

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 3, 2020
• Study Start: June 11, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)