search
Back to results

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
Hospital Ana Nery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Ana Neri - MRI unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sildenafil

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 2, 2013
Last Updated
November 6, 2013
Sponsor
Hospital Ana Nery
search

1. Study Identification

Unique Protocol Identification Number
NCT01936350
Brief Title
Sildenafil Impact on Ventricular Function in Patients With Heart Failure
Official Title
Sildenafil Impact on Ventricular Function in Patients With Heart Failure: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Ana Nery

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
12 patients will be in this group. They will take a sildenafil 50mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 patients will be in this group, they will take placebo
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement on ventricular function
Description
Patients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre M Fernandes, Master
Organizational Affiliation
Hospital Ana Nery - Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Ana Neri - MRI unit
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25793988
Citation
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.
Results Reference
derived
Links:
URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisa.jsf
Description
approved by local Institutional Review Board

Learn more about this trial

Sildenafil Impact on Ventricular Function in Patients With Heart Failure

We'll reach out to this number within 24 hrs