Trial Outcomes & Findings for Beta-blockers in Pulmonary Arterial Hypertension (NCT NCT02507011)

Last Updated: 2020-06-16

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 months

Results posted on

2020-06-16

Participant milestones
Measure	Carvedilol First, Then Placebo Participants in this arm received Carvedilol first	Placebo First, Then Carvedilol Participants in this arm received placebo first
First Intervention STARTED	1	1
First Intervention COMPLETED	1	1
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	1	1
Second Intervention COMPLETED	1	1
Second Intervention NOT COMPLETED	0	0

Withdrawal data not reported

Beta-blockers in Pulmonary Arterial Hypertension

Baseline characteristics by cohort
Measure	All Participants n=2 Participants Crossover Design: All participants pooled at baseline
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 10.6 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

Timeframe: 6 months

Outcome measures
Measure	Carvedilol n=2 Participants Beta Blocker Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo	Placebo n=2 Participants General Placebo Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo
Mean Change in Right Ventricular Ejection Fraction as Measured by Cardiac MRI	10 percent Standard Deviation 4	2.5 percent Standard Deviation 2

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Carvedilol n=2 participants at risk Beta Blocker Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo	Placebo n=2 participants at risk General Placebo Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo
General disorders HF Exaceberation/Electrolyte Imbalance	50.0% 1/2 • Number of events 3 • 13 months	50.0% 1/2 • Number of events 1 • 13 months

Other adverse events
Measure	Carvedilol n=2 participants at risk Beta Blocker Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo	Placebo n=2 participants at risk General Placebo Carvedilol: Beta-adrenergic receptor blocker Placebo: Placebo
General disorders Fatigue	50.0% 1/2 • Number of events 1 • 13 months	50.0% 1/2 • Number of events 1 • 13 months
General disorders Hypotension	50.0% 1/2 • Number of events 1 • 13 months	0.00% 0/2 • 13 months
General disorders Fluid Retention	50.0% 1/2 • Number of events 1 • 13 months	50.0% 1/2 • Number of events 1 • 13 months
Gastrointestinal disorders Constipation	0.00% 0/2 • 13 months	50.0% 1/2 • Number of events 2 • 13 months
Gastrointestinal disorders Gastroenteritis	0.00% 0/2 • 13 months	50.0% 1/2 • Number of events 2 • 13 months

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