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Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

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ClinicalTrials.gov Identifier: NCT01815502
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Single Ventricle Heart Disease After Fontan Surgery
Intervention Diagnostic Test: Cardiac catheterization
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sildenafil Sugar Pill
Hide Arm/Group Description

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Sildenafil Sugar Pill Total
Hide Arm/Group Description

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
10
(6 to 17)
8
(5 to 15)
8
(5 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
3
  30.0%
6
  30.0%
Male
7
  70.0%
7
  70.0%
14
  70.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic
1
  10.0%
0
   0.0%
1
   5.0%
Not Hispanic
9
  90.0%
10
 100.0%
19
  95.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title End-systolic Elastance
Hide Description end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)
Time Frame 10 minutes after imitation of dobutamine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Sugar Pill
Hide Arm/Group Description:

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes.

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Overall Number of Participants Analyzed 10 9
Mean (Inter-Quartile Range)
Unit of Measure: Ees in mmHg/ml/m2
0.85
(0.01 to 1.5)
1.8
(0.74 to 2.2)
2.Secondary Outcome
Title End-diastolic Pressure Volume Relationship
Hide Description End-diastolic pressure volume relationship (EDPVR) is a measure of diastolic (relaxation) heart function
Time Frame 10 minutes after imitation of dobutamine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Sugar Pill
Hide Arm/Group Description:

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Overall Number of Participants Analyzed 10 9
Mean (Inter-Quartile Range)
Unit of Measure: mmHg/ms
499
(367 to 899)
953
(654 to 1482)
3.Other Pre-specified Outcome
Title Ventricular-arterial Coupling
Hide Description Ventricular-arterial coupling is a measure of efficiency of ventricular work in response to the work created by the vascular tree
Time Frame 10 minutes after imitation of dobutamine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dobutamine + Sildenafil Dobutamine + Placebo
Hide Arm/Group Description:

Sildenafil will be given an one time dose 30 to 90 minutes prior to cardiac catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Cardiac catheterization: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to cardiac catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Cardiac catheterization: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.

Overall Number of Participants Analyzed 10 10
Mean (Inter-Quartile Range)
Unit of Measure: ratio
0.01
(-0.39 to 0.25)
0.86
(0.26 to 1.3)
4.Other Pre-specified Outcome
Title Preload Augmentation
Hide Description Preload augmentation is a measure of how quickly the heart fills with blood during exercise
Time Frame 10 minutes after imitation of dobutamine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Sugar Pill
Hide Arm/Group Description:

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Overall Number of Participants Analyzed 10 9
Mean (Inter-Quartile Range)
Unit of Measure: ml/m^2
0.04
(0.01 to 0.08)
0.08
(0.06 to 0.14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sildenafil Sugar Pill
Hide Arm/Group Description

Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Dobutamine: Patients will receive a dobutamine infusion during catheterization.

All-Cause Mortality
Sildenafil Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Sildenafil Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Cardiac disorders     
Hypotension   0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sildenafil Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Blood and lymphatic system disorders     
Bleeding   0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Andrew M Atz
Organization: MUSC
Phone: 843-876-1698
EMail: atzam@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01815502    
Other Study ID Numbers: PVL Fontan
AHA ( Other Grant/Funding Number: American Heart Association )
First Submitted: March 19, 2013
First Posted: March 21, 2013
Results First Submitted: July 12, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018