Trial Outcomes & Findings for Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure (NCT NCT02053246)

NCT ID: NCT02053246

Last Updated: 2022-02-10

Results Overview

Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: baseline - 18 weeks
• Results posted on: 2022-02-10

Participant Flow

Participant milestones

Measure	Nebivolol Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Overall Study STARTED	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Nebivolol Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

2 patients withdrew before measurement

Baseline characteristics by cohort

Measure	Nebivolol n=11 Participants Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Age, Continuous	65.8 years STANDARD_DEVIATION 9.8 • n=11 Participants
Sex: Female, Male Female	9 Participants n=11 Participants
Sex: Female, Male Male	2 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	0 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	4 Participants n=11 Participants
Race (NIH/OMB) White	6 Participants n=11 Participants
Race (NIH/OMB) More than one race	1 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants
Weight	93.0 kilograms STANDARD_DEVIATION 29.8 • n=9 Participants • 2 patients withdrew before measurement
Height	164.6 cm STANDARD_DEVIATION 9.4 • n=9 Participants • 2 patients withdrew before measurement
Systolic Blood Pressure	130.1 mmHg STANDARD_DEVIATION 16.0 • n=9 Participants • 2 patients withdrew before measurement
Diastolic Blood Pressure	68.0 mmHg STANDARD_DEVIATION 12.7 • n=9 Participants • 2 patients withdrew before measurement
Mean Pulmonary Artery Pressure	35.2 mmHg STANDARD_DEVIATION 7.2 • n=9 Participants • 2 patients withdrew before measurement
Pulmonary Artery Wedge Pressure	19.6 mmHg STANDARD_DEVIATION 3.7 • n=9 Participants • 2 patients withdrew before measurement

PRIMARY outcome

Timeframe: baseline - 18 weeks

Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure

Outcome measures

Measure	Nebivolol n=7 Participants Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Changes in Pulmonary Vascular Pressure Mean Pulmonary Artery Pressure Change	0.43 mmHg Standard Deviation 6.32
Changes in Pulmonary Vascular Pressure Pulmonary Artery Wedge Pressure Change	1.0 mmHg Standard Deviation 7.0

SECONDARY outcome

Timeframe: baseline - 18 weeks

Population: Only patients who were able to complete walk tests at baseline and final study visits.

Difference in 6-minute walk distance between baseline and 18 weeks.

Outcome measures

Measure	Nebivolol n=4 Participants Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Changes in 6-minute Walk Distance	-44.0 feet Standard Deviation 299.8

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nebivolol n=9 participants at risk Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
General disorders Dizziness	11.1% 1/9 • Number of events 1 • Data were collected from enrollment until completion of final study visit at week 18.
Renal and urinary disorders Fluid retention	11.1% 1/9 • Number of events 1 • Data were collected from enrollment until completion of final study visit at week 18.

Additional Information

Dr. Julio Duarte

University of Florida

Phone: 352-273-8132

Email: juliod@cop.ufl.edu

Results disclosure agreements

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