- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292483
Pulmonary Capillary Recruitment in Fontan Patients
Pulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Judith Therrien, MD
- Phone Number: 514-340-8232
- Email: judith.therrien@mcgill.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Jewish General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capillary surface area
Time Frame: 30 minutes
|
Measurement of functional capillary surface area pre and post inhaled nitric oxide
|
30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Langleben, MD, Jewish General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Diseases
- Heart Defects, Congenital
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 1900-5, 00-034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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