Trial Outcomes & Findings for The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation (NCT NCT00964782)

NCT ID: NCT00964782

Last Updated: 2019-03-26

Results Overview

A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: baseline to 1 hour
• Results posted on: 2019-03-26

Participant Flow

One subject withdrew consent before being randomized and subsequent medication administered.

Participant milestones

Measure	Sildenafil Crossover to Placebo Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	1	0
Overall Study STARTED	8	8

Reasons for withdrawal

Measure	Sildenafil Crossover to Placebo Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Baseline characteristics by cohort

Measure	Sildenafil Crossover to Placebo n=8 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 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
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 1 hour

A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test

Outcome measures

Measure	Sildenafil Crossover to Placebo n=7 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) Sildenafil VO2	39.4 ml/min/kg Standard Error 2.6	36.8 ml/min/kg Standard Error 2.4
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) Placebo VO2	41.2 ml/min/kg Standard Error 3.4	34.4 ml/min/kg Standard Error 2.8

PRIMARY outcome

Timeframe: baseline to 1 hour

A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test

Outcome measures

Measure	Sildenafil Crossover to Placebo n=7 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
The Change in Exercise Capacity Measured Via Exercise Time Sildenafil Time	11.6 minutes Standard Error 0.6	10.5 minutes Standard Error 0.4
The Change in Exercise Capacity Measured Via Exercise Time Placebo Time	12.1 minutes Standard Error 0.8	10.5 minutes Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline to 1 Hour

A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test

Outcome measures

Measure	Sildenafil Crossover to Placebo n=7 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
The Change in Exercise Capacity Measured Via Maximum Heart Rate Sildenafil Heart Rate	182.3 beats per minute Standard Error 6.4	175.4 beats per minute Standard Error 6.9
The Change in Exercise Capacity Measured Via Maximum Heart Rate Placebo Heart Rate	182.6 beats per minute Standard Error 7.2	167.8 beats per minute Standard Error 7.0

SECONDARY outcome

Timeframe: Baseline to 1 Hour

A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test

Outcome measures

Measure	Sildenafil Crossover to Placebo n=7 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. Sildenafil minimum oxygen saturation %	94.1 Percentage of oxygen saturation Standard Error 1.0	94.6 Percentage of oxygen saturation Standard Error 0.7
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. Placebo minimum oxygen saturation %	93.1 Percentage of oxygen saturation Standard Error 0.8	93.8 Percentage of oxygen saturation Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline to 1 hour

A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute

Outcome measures

Measure	Sildenafil Crossover to Placebo n=7 Participants Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossover to Sidenafil n=8 Participants Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). Sildenafil Metabolic Equivalent	13.6 Mets Standard Error 0.7	12.4 Mets Standard Error 0.5
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). Placebo Metabolic Equivalent	14.1 Mets Standard Error 0.9	12.1 Mets Standard Error 0.6

Adverse Events

Sildenafil Crossed Over to Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Crossed Over to Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sildenafil Crossed Over to Placebo n=15 participants at risk Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises.	Placebo Crossed Over to Sildenafil n=15 participants at risk Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
Skin and subcutaneous tissue disorders Flushed skin	6.7% 1/15 • Number of events 1	0.00% 0/15

Additional Information

Compliance Specialist

Milton S. Hershey Medical Center

Phone: 7175310003

Email: clinicaltrials.gov@pennstatehealth.psu.edu

Results disclosure agreements

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