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Effects of Viagra on Heart Function in Patients With Heart Failure

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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:
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
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
Hide 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)
Arm/Group Title Sildenafil First Placebo Second Placebo First Sildenafil Second Total
Hide 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
Hide 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
1.Primary Outcome
Title Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients (10) that completed the protocol were analyzed.
Arm/Group Title Sildenafil First Then Placebo Placebo First Then Sildenafil
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil First Then Placebo Placebo First Then Sildenafil
Hide 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)
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
Hide 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   --/--   --/-- 
Hide 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%) 
Hide 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%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Robert C. Bahler, MD
Organization: MetroHealth Medical Center
Phone: 216 778-2431
EMail: rbahler@metrohealth.org
Layout table for additonal information
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