Trial Outcomes & Findings for Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis (NCT NCT01060020)

NCT ID: NCT01060020

Last Updated: 2018-04-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 60 minutes after drug administered
• Results posted on: 2018-04-25

Participant Flow

Participants stratified according to ejection fraction and randomized to either Sildenafil 40mg and 80mg Groups were combined into a single Arm/Group for analysis as pre-specified in the study protocol.

Participant milestones

Measure	Sildenafil 40mg or 80mg A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Baseline characteristics by cohort

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Age, Continuous	86 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 60 minutes after drug administered

Outcome measures

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.	-25 percent change Interval -32.0 to -21.0

SECONDARY outcome

Timeframe: Baseline and 60 minutes after drug administered

Outcome measures

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.	-29 percent change Interval -49.0 to -13.0

SECONDARY outcome

Timeframe: Baseline and 60 minutes after drug administered

Cardiac index is cardiac output divided by body surface area.

Outcome measures

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Percent Change in Cardiac Index.	4 percent change Interval -4.0 to 12.0

SECONDARY outcome

Timeframe: Baseline and 60 minutes after drug administered

Measurements of the load independent index of diastolic filling were made with the parameterized diastolic filling formalism as previously described and validated with the use of transmitral Doppler E waves recorded during different respiratory states (regular breathing and held expiration and inspiration).

Outcome measures

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Load Independent Index of Diastolic Filling. Baseline	1.02 unitless Standard Deviation 0.07
Load Independent Index of Diastolic Filling. 60 minutes	1.03 unitless Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline and 60 minutes after drug administered

Global longitudinal strain was measured at baseline and 60 minutes after drug administration.

Outcome measures

Measure	Sildenafil 40mg or 80mg n=20 Participants A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Global Longitudinal Strain Baseline	-13.5 percent Standard Deviation 4.3
Global Longitudinal Strain 60 minutes	-13.8 percent Standard Deviation 3.9

Adverse Events

Sildenafil 40mg or 80mg

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sildenafil 40mg or 80mg n=20 participants at risk A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Cardiac disorders Hypotension	10.0% 2/20
Cardiac disorders SVT	5.0% 1/20

Other adverse events

Measure	Sildenafil 40mg or 80mg n=20 participants at risk A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Cardiac disorders hypertensive emergency	5.0% 1/20

Additional Information

Brian R. Lindman, MD, Assistant Professor of Medicine

Washington University School of Medicine

Phone: 314-747-3617

Email: brlindman@wustl.edu

Results disclosure agreements

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