Effects of Viagra on Heart Function in Patients With Heart Failure

• ClinicalTrials.gov Identifier: NCT00781508
• Recruitment Status: Completed
• First Posted: October 29, 2008
• Results First Posted: June 23, 2014
• Last Update Posted: July 2, 2014
• Sponsor: MetroHealth Medical Center
• Collaborator: National Center for Research Resources (NCRR)
• Information provided by (Responsible Party): Robert Bahler, MetroHealth Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Heart Failure; Left Ventricular Dysfunction
• Interventions: Drug: sildenafil; Other: Placebo
• Enrollment: 10

Participant Flow

Recruitment Details	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.
Pre-assignment Details	More than 50 patients had to be excluded due to their already taking nitrates for their heart failure.

Arm/Group Title	Sildenafil Then Placebo	Placebo Then Sildenafil
Arm/Group Description	Effect of sildenafil on left ventricular filling pressures in patients with heart failure	Effect of Sildenafil on left ventricular function
Period Title: Overall Study
Started	5 [1]	5 [1]
Completed	5	5
Not Completed	0	0
[1] First Intervention (1 day)", "Washout (48 hours)", "Second Intervention (1 day)

Baseline Characteristics

Arm/Group Title		Sildenafil First Placebo Second	Placebo First Sildenafil Second	Total
Arm/Group Description		Effect of sildenafil on left ventricular filling pressures in patients with heart failure	Effect of placebo on left ventricular filling pressures in patients with heart failure	Total of all reporting groups
Overall Number of Baseline Participants		5	5	10
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	5 participants	10 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	4 80.0%	3 60.0%	7 70.0%
	>=65 years	1 20.0%	2 40.0%	3 30.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	5 participants	5 participants	10 participants
		64 (12)	64 (12)	64 (12)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	5 participants	10 participants
	Female	1 20.0%	0 0.0%	1 10.0%
	Male	4 80.0%	5 100.0%	9 90.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	5 participants	5 participants	10 participants
		5	5	10

Outcome Measures

1. Primary Outcome

Title	Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil
Description	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
Time Frame	Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sildenafil First Then Placebo	Placebo First Then Sildenafil
Arm/Group Description:	sildenafil 50 mg administered orally, placebo administered orally 48 hrs later	placebo administered orally, then sildenafil orally 48 hrs later
Overall Number of Participants Analyzed	5	5
Mean (Standard Deviation); Unit of Measure: E/e' ratio
	16.7 (6.9)	16.4 (6.5)

2. Secondary Outcome

Title	The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.
Description	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.
Time Frame	Measured 1 hr after oral administration of sildenafil 50 mg

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sildenafil First Then Placebo	Placebo First Then Sildenafil
Arm/Group Description:	Sildenafil 50 mg orally, placebo orally 2 days later.	placebo orally, then sildenafil 50 mg orally 2 days later.
Overall Number of Participants Analyzed	5	5
Mean (Standard Deviation); Unit of Measure: meters
	210 (34)	219 (40)

Adverse Events

Time Frame	The study took place over a 1 year interval
Adverse Event Reporting Description	Patients were observered for any side effects or adverse reactions for 2 hrs following the administration of either sildenafil or placebo.
Arm/Group Title	Sildenafil First Then Placebo	Placebo First Then Sildenafil
Arm/Group Description	Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure	Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
All-Cause Mortality
	Sildenafil First Then Placebo	Placebo First Then Sildenafil
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Sildenafil First Then Placebo	Placebo First Then Sildenafil
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/5 (0.00%)	0/5 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Sildenafil First Then Placebo	Placebo First Then Sildenafil
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/5 (0.00%)	0/5 (0.00%)

Limitations and Caveats

The study was limited by the small number of participants. Additionally, the inclusion criterion of a systolic pulmonary artery pressure of > 40 mmHg was no longer present in the majority of patients at the time they presented for study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Robert C. Bahler, MD
• Organization: MetroHealth Medical Center
• Phone: 216 778-2431
• EMail: rbahler@metrohealth.org

• Responsible Party: Robert Bahler, MetroHealth Medical Center
• ClinicalTrials.gov Identifier: NCT00781508
• Other Study ID Numbers: MO1RR000080; Grant Number UL1 RR024989 ( Other Grant/Funding Number: CWRU-CTSC ); ULI RR024989 ( Other Grant/Funding Number: NIH/NCRR CWRU-CTSC )
• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Results First Submitted: April 22, 2013
• Results First Posted: June 23, 2014
• Last Update Posted: July 2, 2014