Status:
UNKNOWN
Pulmonary Capillary Recruitment in Fontan Patients
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
National and Kapodistrian University of Athens
Tel Aviv University
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
18-60 years
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 inhalati...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
June 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04292483
Start Date
June 11 2020
End Date
December 31 2023
Last Update
April 7 2022
Active Locations (1)
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1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2