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Completed

NCT Number: NCT01936350

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Ana Neri - MRI unit

Salvador, Estado de Bahia, 40000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil

Drug

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

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Ana Nery

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2013
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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