Trial Outcomes & Findings for Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease (NCT NCT01319045)

Results Overview

Number of Participants with adverse events, specifically mortality and heart failure.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

3 months

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Iloprost Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months. Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iloprost n=3 Participants Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months. Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Number of adverse events.

Number of Participants with adverse events, specifically mortality and heart failure.

Outcome measures

Outcome measures
Measure	Iloprost n=3 Participants Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months. Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
Safety and Tolerability	0 participants

SECONDARY outcome

Timeframe: 3 months

Population: unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained

Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained

Change in serum BNP level

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained

Change in quality of life as assessed by SF-36 QOL

Outcome measures

Outcome data not reported

Adverse Events

Iloprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamil Aboulhosn

UCLA

Phone: 310-825-5950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place