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Pulmonary Capillary Recruitment in Fontan Patients

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ClinicalTrials.gov Identifier: NCT04292483
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
Tel Aviv University
Old Dominion University
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital

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
Congenital Heart Disease Drug: Nitric Oxide

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Study Type : Observational
Estimated 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 : June 11, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Nitric Oxide
    Inhaled nitric oxide to increase pulmonary capillary perfusion


Primary Outcome Measures :
  1. Functional capillary surface area [ Time Frame: 30 minutes ]
    Measurement of functional capillary surface area pre and post inhaled nitric oxide



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with Fontan failure as described above
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:

  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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292483


Contacts
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Contact: David Langleben, MD 5143407531 david.langleben@mcgill.ca
Contact: Judith Therrien, MD 514-340-8232 judith.therrien@mcgill.ca

Locations
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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: David Langleben, MD         
Sponsors and Collaborators
Jewish General Hospital
National and Kapodistrian University of Athens
Tel Aviv University
Old Dominion University
Investigators
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Principal Investigator: David Langleben, MD Jewish General Hospital
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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: March 3, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents