Sildenafil Impact on Ventricular Function in Patients With Heart Failure

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT01936350
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-06
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	12 patients will be in this group. They will take a sildenafil 50mg.
Placebo	Placebo	12 patients will be in this group, they will take placebo

Primary Outcome Measures

Name	Time	Method
Improvement on ventricular function	one hour	Patients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use

Trial Locations

Locations (1)

Hospital Ana Neri - MRI unit; 🇧🇷 Salvador, Bahia, Brazil