Sildenafil Impact on Ventricular Function in Patients With Heart Failure

NCT ID: NCT01936350

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Keywords

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Heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sildenafil

12 patients will be in this group. They will take a sildenafil 50mg.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type 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

12 patients will be in this group, they will take placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Placebo group

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ana Nery

OTHER

Sponsor Role lead

Responsible Party

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Andre Duraes, PhD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre M Fernandes, Master

Role: STUDY_DIRECTOR

Hospital Ana Nery - Federal University of Bahia

Locations

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Hospital Ana Neri - MRI unit

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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Fernandes AM, Andrade AC, Barroso ND, Borges IC, Carvalho-Andrade D, Rodrigues Junior ES, Guimaraes LC, Duraes AR, Borges SM, Aras Junior R. The immediate effect of sildenafil on right ventricular function in patients with heart failure measured by cardiac magnetic resonance: a randomized control trial. PLoS One. 2015 Mar 20;10(3):e0119623. doi: 10.1371/journal.pone.0119623. eCollection 2015.

Reference Type DERIVED
PMID: 25793988 (View on PubMed)

Related Links

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Other Identifiers

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05378712.0.0000.0045

Identifier Type: -

Identifier Source: org_study_id