Trial Outcomes & Findings for Targeting the Right Ventricle in Pulmonary Hypertension (NCT NCT01839110)

NCT ID: NCT01839110

Last Updated: 2019-02-05

Results Overview

right ventricular ejection fraction by cardiac MRI

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	Ranolazine Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.	Placebo Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks.	Observational Patients with pulmonary hypertension who have normal RV function (RVEF \>=45%) will undergo same procedures in the observational arm but will not receive an intervention.
Overall Study STARTED	7	6	9
Overall Study COMPLETED	4	4	6
Overall Study NOT COMPLETED	3	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ranolazine n=7 Participants Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.	Placebo n=6 Participants Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks.	Observational n=9 Participants Patients with pulmonary hypertension who have normal RV function (RVEF \>=45%) will undergo same procedures in the observational arm but will not receive an intervention.	Total n=22 Participants Total of all reporting groups
Age, Continuous	53.0 years STANDARD_DEVIATION 19.7 • n=7 Participants	57.7 years STANDARD_DEVIATION 6.8 • n=6 Participants	53.2 years STANDARD_DEVIATION 17.9 • n=9 Participants	54.4 years STANDARD_DEVIATION 15.9 • n=22 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	4 Participants n=6 Participants	6 Participants n=9 Participants	13 Participants n=22 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	2 Participants n=6 Participants	3 Participants n=9 Participants	9 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	6 participants n=6 Participants	9 participants n=9 Participants	22 participants n=22 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Completers

right ventricular ejection fraction by cardiac MRI

Outcome measures

Measure	Ranolazine n=4 Participants Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.	Placebo n=3 Participants Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks.	Observational n=6 Participants Patients with pulmonary hypertension who have normal RV function (RVEF \>=45%) will undergo same procedures in the observational arm but will not receive an intervention.
Changes in Right Ventricular Ejection Fraction	5.8 percentage Standard Error 2.0	-4.7 percentage Standard Error 3.2	0.49 percentage Standard Error 3.2

Adverse Events

Ranolazine

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Observational

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranolazine n=7 participants at risk Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.	Placebo n=6 participants at risk Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks.	Observational n=6 participants at risk；n=9 participants at risk Patients with pulmonary hypertension who have normal RV function (RVEF \>=45%) will undergo same procedures in the observational arm but will not receive an intervention.
Cardiac disorders heart failure hospitalization	14.3% 1/7 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	16.7% 1/6 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/9 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days

Other adverse events

Measure	Ranolazine n=7 participants at risk Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.	Placebo n=6 participants at risk Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks.	Observational n=6 participants at risk；n=9 participants at risk Patients with pulmonary hypertension who have normal RV function (RVEF \>=45%) will undergo same procedures in the observational arm but will not receive an intervention.
Gastrointestinal disorders nausea	28.6% 2/7 • Number of events 2 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	16.7% 1/6 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
Cardiac disorders chest pain	0.00% 0/7 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	16.7% 1/6 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
Respiratory, thoracic and mediastinal disorders hemoptysis	0.00% 0/7 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	16.7% 1/6 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
Renal and urinary disorders hyponatremia	14.3% 1/7 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
General disorders fatigue	14.3% 1/7 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
General disorders face edema	14.3% 1/7 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days
Skin and subcutaneous tissue disorders hair loss	0.00% 0/7 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	16.7% 1/6 • Number of events 1 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days	0.00% 0/6 • 7 months. 6 months of trial and adverse events are gathered for 30 additional days

Additional Information

Dr. Yuchi Han

University of Pennsylvania

Phone: 215-662-2855

Email: yuchi.han@uphs.upenn.edu

Results disclosure agreements

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

Restriction type: OTHER