Trial Outcomes & Findings for Sildenafil in Heart Failure With Reactive Pulmonary Hypertension (NCT NCT02304705)

Last Updated: 2019-11-07

Results Overview

In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

Baseline and 90 days

Results posted on

2019-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo three times per day, orally Placebo: One capsule three times daily by mouth for 90 days	Sildenafil Sildenafil 20 mg three times per day, orally for 90 days
Overall Study STARTED	16	17
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo three times per day, orally Placebo: One capsule three times daily by mouth for 90 days	Sildenafil Sildenafil 20 mg three times per day, orally for 90 days
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	2	4
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Placebo three times per day, orally Placebo: One capsule TID PO for 90 days	Sildenafil n=17 Participants Sildenafil 20 mg three times per day, orally Sildenafil: 20 mg TID PO for 90 days	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 90 days

Population: Several participants were not analyzed for several reasons including death, failure to follow-up, PI withdrawal or subject withdrawal. In the Sildenafil group, 17 participants were consented while 10 were analyzed. In the Placebo group, 16 subjects were consented and 12 were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo three times per day, orally Placebo: One capsule TID PO for 90 days	Sildenafil n=10 Participants Sildenafil 20 mg three times per day, orally Sildenafil: 20 mg TID PO for 90 days
Change in Exercise Tolerance	228 feet Standard Error 174	135 feet Standard Error 22

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 90 day

Right ventricular function will be measured using tricuspid annular plane systolic excursion via two dimensional apical four-chamber echocardiography. Data will be collected at baseline and after 90 days of treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 90 days

cardiac output will be calculated by multiplying stroke volume by heart rate. Cardiac index will be calculated by dividing cardiac output (Liters/minute) by body surface area (meters squared). Data will be collected at baseline and the end of treatment (90 days)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 90 days

Pulmonary vascular resistance will be determined by right heart catheterization. Data will be collected at baseline and at the end of treatment (90 days)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 90 days

through standard cuff method, participants will have blood pressure measured to determine systolic and diastolic blood pressure as well as mean arterial pressure. data will be collected at baseline and 90 days.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maya Guglin

University of Kentucky

Phone: 859-323-4738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place