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Phosphodiesterase Type 5 Inhibitor
Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation
Phase 3
Waitlist Available
Led By Jonathan Howlett, FRCPC
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 85 (final sae review)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing whether or not a drug called sildenafil can help reduce the risk of right heart failure in people who are scheduled to have surgery for advanced heart failure.
Eligible Conditions
- Congestive Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to day 85 (final sae review)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to day 85 (final sae review)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proliferative vitreoretinopathy
Secondary study objectives
Hospitalization
ICU
Inotrope requirement
+2 moreOther study objectives
Safety: Adverse drug reactions
Safety: All-cause mortality
Safety: Drug interruptions
+7 moreSide effects data
From 2013 Phase 4 trial • 105 Patients • NCT0032329714%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Vertigo
10%
Palpitations
10%
Bronchitis
10%
Nasopharyngitis
10%
Flushing
8%
Respiratory tract infection
6%
Dyspnoea
6%
Right ventricular failure
6%
Depression
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Anaemia
4%
Bronchopneumonia
2%
Pancreatic neoplasm
2%
Cough
2%
Walking distance test abnormal
2%
Hypoxia
2%
Uterine haemorrhage
2%
Breast cancer
2%
Cardiac failure
2%
Acute coronary syndrome
2%
Haemoglobin decreased
2%
Death
2%
Cardiovascular disorder
2%
Chest discomfort
2%
Coronary artery disease
2%
Haemoptysis
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Mitral valve incompetence
2%
Inguinal hernia
2%
Circulatory collapse
2%
General physical health deterioration
2%
Urinary tract infection
2%
Asthenia
2%
Respiratory syncytial virus infection
2%
Gangrene
2%
Sinusitis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: sildenafil citrateExperimental Treatment1 Intervention
Following enrolment, participants will be given an initial dose of sildenafil 20 mg. If tolerated, a schedule of 20 mg three times daily (tid) will be initiated. Dosage will be titrated over 3-4 days to the target dose of 40 mg tid. If the initial dose is not tolerated, the participant will be exited from the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,158 Total Patients Enrolled
University of CalgaryLead Sponsor
811 Previous Clinical Trials
889,552 Total Patients Enrolled
Jonathan Howlett, FRCPCPrincipal InvestigatorUniversity of Calgary