Trial Outcomes & Findings for Effects of Viagra on Heart Function in Patients With Heart Failure (NCT NCT00781508)

Results Overview

Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil

Results posted on

2014-07-02

Participant Flow

Patients were recruited from the Heart Failure Clinic at MetroHealth Medical Center over a 12 month interval. Recruitment was slow due to the fact that many of the patients were already perscirbed nitrates and so were ineligible for the study.

More than 50 patients had to be excluded due to their already taking nitrates for their heart failure.

Participant milestones

Participant milestones
Measure	Sildenafil Then Placebo Effect of sildenafil on left ventricular filling pressures in patients with heart failure	Placebo Then Sildenafil Effect of Sildenafil on left ventricular function
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Viagra on Heart Function in Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sildenafil First Placebo Second n=5 Participants Effect of sildenafil on left ventricular filling pressures in patients with heart failure	Placebo First Sildenafil Second n=5 Participants Effect of placebo on left ventricular filling pressures in patients with heart failure	Total n=10 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=5 Participants	64 years STANDARD_DEVIATION 12 • n=7 Participants	64 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil

Population: All patients (10) that completed the protocol were analyzed.

Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e

Outcome measures

Outcome measures
Measure	Sildenafil First Then Placebo n=5 Participants sildenafil 50 mg administered orally, placebo administered orally 48 hrs later	Placebo First Then Sildenafil n=5 Participants placebo administered orally, then sildenafil orally 48 hrs later
Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil	16.7 E/e' ratio Standard Deviation 6.9	16.4 E/e' ratio Standard Deviation 6.5

SECONDARY outcome

Timeframe: Measured 1 hr after oral administration of sildenafil 50 mg

A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.

Outcome measures

Outcome measures
Measure	Sildenafil First Then Placebo n=5 Participants sildenafil 50 mg administered orally, placebo administered orally 48 hrs later	Placebo First Then Sildenafil n=5 Participants placebo administered orally, then sildenafil orally 48 hrs later
The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.	210 meters Standard Deviation 34	219 meters Standard Deviation 40

Adverse Events

Sildenafil First Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First Then Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert C. Bahler, MD

MetroHealth Medical Center

Phone: 216 778-2431

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place