Skip to content

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936350
Enrollment
24
Registered
2013-09-06
Start date
2013-09-30
Completion date
2013-11-30
Last updated
2013-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure

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.

Interventions

DRUGSildenafil

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.

DRUGPlacebo

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.

Sponsors

Hospital Ana Nery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement on ventricular functionone hourPatients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026