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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

Tracking Information
First Submitted Date  ICMJE October 28, 2008
First Posted Date  ICMJE October 29, 2008
Results First Submitted Date  ICMJE April 22, 2013
Results First Posted Date  ICMJE June 23, 2014
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE December 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil [ Time Frame: Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
The primary outcome measure is a fall in the left ventricular filling pressure in association with administration of sildenafil [ Time Frame: The left ventricular filling presure will be assessed at 60 minutes after the administration of sildenafil ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
A secondary outcome is the distance walked with the 6-minute walk test after the administration of sildenafil [ Time Frame: Determned at the end of the 6-minute walk test ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Viagra on Heart Function in Patients With Heart Failure
Official Title  ICMJE Single Dose Sildenafil in Heart Failure Patients Improves 6-minute Walk Test by a Reduction in Left Ventricular Filling Pressure
Brief Summary Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity. In these studies sildenafil caused a reduction in the pulmonary and systemic vascular resistances, improved pulmonary gas diffusion and perhaps increased cardiac output. It is uncertain if left ventricular filling pressures are reduced and whether there is improvement in left ventricular relaxation. The investigators hypothesize that in heart failure patients the improvement in exercise capacity associated with sildenafil is related to a significant reduction in left ventricular filling pressures. The investigators propose to study 20 patients with stable but moderately symptomatic heart failure. The study design is a randomized cross-over trial of the administration of a single dose of sildenafil 50 mg or a matching placebo. Exercise capacity will be determined before and after the oral administration of sildenafil 50 mg or placebo. Left ventricular filling pressures will be assessed by Doppler echocardiography and the serum level of B-type natriuretic peptide (BNP is known to increase with higher left ventricular filling pressures). After an initial echocardiogram and performing a 6 minute walk test, the patient will then be given either sildenafil or a matching placebo in a randomized double-blind fashion. One hr later a blood sample for serum BNP, the echocardiogram and the 6 minute walk test will be repeated.
Detailed Description Sildenafil (Viagra) has been extensively studied in patients with idiopathic pulmonary hypertension. It reduces pulmonary vascular resistance, improves exercise capacity and is now an approved therapy for this condition. Heart failure (HF) patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity. In HF sildenafil causes a reduction in the pulmonary and systemic vascular resistances, improves pulmonary gas diffusion and perhaps increases cardiac output. It is uncertain if left ventricular filling pressures are reduced and whether there is improvement in left ventricular relaxation. We hypothesize that in HF patients the improvement in exercise capacity associated with sildenafil is related to a significant reduction in left ventricular filling pressures. We propose to study 10 patients with stable, symptomatic HF Class III. The study design is a randomized cross-over assignment of the administration of a single oral dose of sildenafil 50 mg or a matching placebo. Patients will be excluded if walking is impaired due to non-cardiac conditions or if they are taking nitrates. Exercise capacity will be determined before and 60 minutes after the oral administration of sildenafil 50 mg or placebo. The difference in the standardized 6 minute walk test (distance patient is able to walk over a 6 minute interval) will be used to assess exercise capacity. Left ventricular filling pressures will be assessed by Doppler echocardiography and the serum level of B-type natriuretic peptide (BNP). Evaluation of left ventricular relaxation will be determined by Doppler echocardiography techniques. Each patient will have a blood sample for BNP, an initial echocardiogram and perform a 6 minute walk test. They will then be given a single dose of either sildenafil or a matching placebo in a randomized double-blind fashion. The randomization was performed so that half of the group would receive the placebo on the initial test and sildenafil on the subsequent test and the other half would have the reverse sequence. One hr after the medication/placebo administration a blood sample for serum BNP, the echocardiogram and the 6 minute walk test will be repeated. After completion of the above protocol, the patient will return in 48 hrs and the protocol will be repeated with the predetermined assignment of either placebo or sildenafil.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Left Ventricular Dysfunction
Intervention  ICMJE
  • Drug: sildenafil
    Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
    Other Name: Viagra
  • Other: Placebo
    Changes in left ventricular filling pressure 1 hour after oral administration of placebo
Study Arms  ICMJE
  • Experimental: sildenafil
    Effect of oral administration of a single dose of sildenafil 50 mg on left ventricular filling pressures as evaluated 1 hr after sildenafil administration in patients with heart failure
    Interventions:
    • Drug: sildenafil
    • Other: Placebo
  • Placebo Comparator: placebo
    Inactive placebo prepared to mimic the appearance of sildenafil.
    Interventions:
    • Drug: sildenafil
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2008)
20
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with Class III congestive heart failure and impaired left ventricular systolic function.
  • A prior BNP level ≥ 200 pg/mL.
  • Previously documented systolic pulmonary artery pressure >40 mmHg.
  • Clinically stable for a minimum of 6 weeks.
  • Able to give informed consent,

Exclusion Criteria:

  • Unable to give informed consent.
  • Currently taking nitrates.
  • A HF exacerbation within the past 6 weeks.
  • Co-morbid conditions that could limit their walking.
  • Have a resting systolic blood pressure < 110 mmHg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00781508
Other Study ID Numbers  ICMJE MO1RR000080
Grant Number UL1 RR024989 ( Other Grant/Funding Number: CWRU-CTSC )
ULI RR024989 ( Other Grant/Funding Number: NIH/NCRR CWRU-CTSC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert Bahler, MetroHealth Medical Center
Original Responsible Party Robert C Bahler, MD, MetroHealth Medical Center
Current Study Sponsor  ICMJE MetroHealth Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Robert C Bahler, MD MetroHealth Medical Center
PRS Account MetroHealth Medical Center
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP