Sildenafil Impact on Ventricular Function in Patients With Heart Failure

November 6, 2013 updated by: Andre Duraes, PhD, Hospital Ana Nery

Sildenafil Impact on Ventricular Function in Patients With Heart Failure: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40000
        • Hospital Ana Neri - MRI unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ana Nery

Investigators

  • Study Director: Andre M Fernandes, Master, Hospital Ana Nery - Federal University of Bahia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (ESTIMATE)

September 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05378712.0.0000.0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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