Chronic Sildenafil Treatment in Heart Failure
Chronic PDE5-Inhibition With Sildenafil Improves Diastolic Function, Cardiac Geometry and Clinical Status in Patients With Stable HF: A 1-Year Prospective Randomized, Placebo-Controlled Study
1 other identifier
interventional
50
1 country
2
Brief Summary
In heart failure (HF), a defective nitric oxide (NO) signaling may be involved in left ventricular (LV) diastolic abnormalities and LV remodelling progression. PDE5-inhibition, by blocking NO degradation and overexpressing cellular cyclic guanosine monophosphate (cGMP) pathways might be beneficial. Several short term studies have demonstrated safety and clinical improvement in stable heart failure (HF) patients. The purpose of this study is to test the effects on LV diastolic function, cardiac geometry and clinical status in a cohort of HF patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 heart-failure
Started Apr 2005
Typical duration for phase_3 heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedSeptember 11, 2009
September 1, 2009
September 3, 2009
September 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular diastolic function
1 year
Secondary Outcomes (4)
Functional capacity
1 year
Quality of life
1 year
Neurohumoral (brain natriuretic peptide)
1 year
Cardiac remodeling
1 year
Study Arms (2)
sildenafil
ACTIVE COMPARATORsildenafil 50 mg three times/day
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- consent to participate in the study after detailed information about procedures, possible clinical benefits and risks;
- negative exercise stress test prior to study initiation;
- forced expiratory volume in 1 sec/forced vital capacity ratio\>70%;
- left ventricular ejection fraction \< 45%, determined by echocardiography.
You may not qualify if:
- subjects unable to complete a maximal exercise test
- systolic blood pressure \> 140 and \<110 mmHg
- diabetes mellitus
- therapy with nitrate preparations
- history of sildenafil intolerance
- significant lung or valvular diseases
- neuromuscular disorders, claudication
- peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Milano
Milan, 20142, Italy
University of Milano
Milan, Italy
Related Publications (1)
Guazzi M, Vicenzi M, Arena R, Guazzi MD. PDE5 inhibition with sildenafil improves left ventricular diastolic function, cardiac geometry, and clinical status in patients with stable systolic heart failure: results of a 1-year, prospective, randomized, placebo-controlled study. Circ Heart Fail. 2011 Jan;4(1):8-17. doi: 10.1161/CIRCHEARTFAILURE.110.944694. Epub 2010 Oct 29.
PMID: 21036891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 11, 2009
Study Start
April 1, 2005
Study Completion
December 1, 2008
Last Updated
September 11, 2009
Record last verified: 2009-09