Trial Outcomes & Findings for Endothelin-1 and Cardiac Allograft Vasculopathy (CAV) (NCT NCT05373108)

Last Updated: 2024-03-12

Results Overview

Macitentan: NTG luminal volume dilation ratio on Intravascular Ultrasound (IVUS). Vasodilation achieved by Macitentan was compared with that after intracoronary nitroglycerin, a maximal dilator of epicardial arteries, to determine the relative contribution of ET-1 to the overall resting vasomotor tone. The contribution of ET-1 to resting vasomotor tone is expressed as the ratio of dilation to Macitentan over the dilation to nitroglycerin.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

End of study week 1 (time of 1 year post-transplant coronary angiogram)

Results posted on

2024-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm A consecutive subset of eligible patients based on inclusion/exclusion criteria will receive a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan will occur on the day of the angiogram). Macitentan: Macitentan is a nonselective endothelin-receptor antagonist (ERA) that is approved for use in pulmonary arterial hypertension (PAH); the use of Macitentan in post-heart transplant patients is considered investigational.
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm A consecutive subset of eligible patients based on inclusion/exclusion criteria will receive a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan will occur on the day of the angiogram). Macitentan: Macitentan is a nonselective endothelin-receptor antagonist (ERA) that is approved for use in pulmonary arterial hypertension (PAH); the use of Macitentan in post-heart transplant patients is considered investigational.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=19 Participants A consecutive subset of eligible patients based on inclusion/exclusion criteria will receive a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan will occur on the day of the angiogram). Macitentan: Macitentan is a nonselective endothelin-receptor antagonist (ERA) that is approved for use in pulmonary arterial hypertension (PAH); the use of Macitentan in post-heart transplant patients is considered investigational.
Age, Continuous	54.2 years n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=99 Participants
Race/Ethnicity, Customized Non-Hispanic White	10 Participants n=99 Participants
Race/Ethnicity, Customized Non-Hispanic Black	1 Participants n=99 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	1 Participants n=99 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants
Region of Enrollment United States	19 participants n=99 Participants

PRIMARY outcome

Timeframe: End of study week 1 (time of 1 year post-transplant coronary angiogram)

Population: Sixteen patients had interpretable IVUS data.

Outcome measures

Outcome measures
Measure	Participants With Progressive Cardiac Allograft Vasculopathy (CAV) at 1-year Post-transplant n=8 Participants A consecutive subset of eligible patients based on inclusion/exclusion criteria received a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan was on the day of the angiogram). Progressive CAV was defined as \> 50th percentile of lumen volume loss measured by 3D IVUS	Participants Without Progressive Cardiac Allograft Vasculopathy (CAV) at 1-year Post-transplant n=8 Participants A consecutive subset of eligible patients based on inclusion/exclusion criteria received a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan was on the day of the angiogram). Progressive CAV was defined as \> 50th percentile of lumen volume loss measured by 3D IVUS
Macitentan: Nitroglycerin (NTG) Luminal Dilation Ratio as Proportion of Vasomotor Tone Attributable to Endothelin-1 (ET-1)	0.33 ratio Interval 0.31 to 0.37	0.30 ratio Interval 0.29 to 0.32

Adverse Events

Intervention Arm

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

Rushi V. Parikh, MD

University of California, Los Angeles

Phone: (310) 825-9011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place