Sildenafil Impact on Ventricular Function in Patients With Heart Failure
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 heart-failure
Started Sep 2013
Shorter than P25 for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 7, 2013
November 1, 2013
2 months
September 2, 2013
November 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement on ventricular function
Patients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use
one hour
Study Arms (2)
Sildenafil
EXPERIMENTAL12 patients will be in this group. They will take a sildenafil 50mg.
Placebo
PLACEBO COMPARATOR12 patients will be in this group, they will take placebo
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ana Neri - MRI unit
Salvador, Estado de Bahia, 40000, Brazil
Related Publications (1)
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.
PMID: 25793988DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andre M Fernandes, Master
Hospital Ana Nery - Federal University of Bahia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 2, 2013
First Posted
September 6, 2013
Study Start
September 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 7, 2013
Record last verified: 2013-11