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Sildenafil Impact on Ventricular Function in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01936350
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery

Brief Summary:
Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or Sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Sildenafil Drug: Placebo Phase 2 Phase 3

Detailed Description:

Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.

The first and second exams will be performed by the same staff. All patients will be evaluated by two, three and four chambers view. Left and right ventricle quantification analyses will be performed by Argus software.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Sildenafil Impact on Ventricular Function in Patients With Heart Failure: Randomized Clinical Trial
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Sildenafil
12 patients will be in this group. They will take a sildenafil 50mg.
Drug: Sildenafil
The intervention in this group is the use of sildenafil 50mg; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the drug.

Placebo Comparator: Placebo
12 patients will be in this group, they will take placebo
Drug: Placebo
This group will use placebo; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the placebo pill.
Other Name: Placebo group




Primary Outcome Measures :
  1. Improvement on ventricular function [ Time Frame: one hour ]
    Patients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients with heart failure in stable clinical condition compatible with New York Heart Association functional class I to III. Eligibility criteria is consent to participate in the study after receiving detailed information about procedures, possible clinical benefits, and risks.

Exclusion Criteria: patients with new diagnosed lesions during the procedure, eg pulmonary mass and important claustrophobia, low blood pressure ( systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg) nitrate or nebivolol use over the last 48 hours, metallic non MRI compatible implantable devices.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936350


Locations
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Brazil
Hospital Ana Neri - MRI unit
Salvador, Bahia, Brazil, 40000
Sponsors and Collaborators
Hospital Ana Nery
Investigators
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Study Director: Andre M Fernandes, Master Hospital Ana Nery - Federal University of Bahia

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andre Duraes, PhD, Doctor, Hospital Ana Nery
ClinicalTrials.gov Identifier: NCT01936350     History of Changes
Other Study ID Numbers: 05378712.0.0000.0045
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Andre Duraes, PhD, Hospital Ana Nery:
Heart failure

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents