Trial Outcomes & Findings for Study of Effects of Sildenafil on Patients With Fontan Heart Circulation (NCT NCT01815502)

NCT ID: NCT01815502

Last Updated: 2018-12-07

Results Overview

end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 10 minutes after imitation of dobutamine
• Results posted on: 2018-12-07

Participant Flow

Participant milestones

Measure	Sildenafil 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.	Sugar Pill 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 Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

Baseline characteristics by cohort

Measure	Sildenafil n=10 Participants 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.	Sugar Pill n=10 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10 years n=5 Participants	8 years n=7 Participants	8 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes after imitation of dobutamine

end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)

Outcome measures

Measure	Sildenafil n=10 Participants 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.	Sugar Pill n=9 Participants 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.
End-systolic Elastance	0.85 Ees in mmHg/ml/m2 Interval 0.01 to 1.5	1.8 Ees in mmHg/ml/m2 Interval 0.74 to 2.2

SECONDARY outcome

Timeframe: 10 minutes after imitation of dobutamine

End-diastolic pressure volume relationship (EDPVR) is a measure of diastolic (relaxation) heart function

Outcome measures

Measure	Sildenafil n=10 Participants 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.	Sugar Pill n=9 Participants 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.
End-diastolic Pressure Volume Relationship	499 mmHg/ms Interval 367.0 to 899.0	953 mmHg/ms Interval 654.0 to 1482.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes after imitation of dobutamine

Ventricular-arterial coupling is a measure of efficiency of ventricular work in response to the work created by the vascular tree

Outcome measures

Measure	Sildenafil n=10 Participants 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.	Sugar Pill n=10 Participants 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.
Ventricular-arterial Coupling	0.01 ratio Interval -0.39 to 0.25	0.86 ratio Interval 0.26 to 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes after imitation of dobutamine

Preload augmentation is a measure of how quickly the heart fills with blood during exercise

Outcome measures

Measure	Sildenafil n=10 Participants 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.	Sugar Pill n=9 Participants 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.
Preload Augmentation	0.04 ml/m^2 Interval 0.01 to 0.08	0.08 ml/m^2 Interval 0.06 to 0.14

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sildenafil n=10 participants at risk 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.	Sugar Pill n=10 participants at risk 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.
Cardiac disorders Hypotension	0.00% 0/10	0.00% 0/10

Other adverse events

Measure	Sildenafil n=10 participants at risk 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.	Sugar Pill n=10 participants at risk 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.
Blood and lymphatic system disorders Bleeding	0.00% 0/10	0.00% 0/10

Additional Information

Dr. Andrew M Atz

MUSC

Phone: 843-876-1698

Email: atzam@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place