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Phosphodiesterase Type 5 Inhibitor

Sildenafil Citrate for Heart Failure

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

Study 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
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to day 85 (final sae review)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to day 85 (final sae review) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proliferative vitreoretinopathy
Secondary outcome measures
Hospitalization
ICU
Inotrope requirement
+2 more
Other outcome measures
Safety: Adverse drug reactions
Safety: All-cause mortality
Safety: Drug interruptions
+7 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Vertigo
10%
Bronchitis
10%
Flushing
10%
Palpitations
10%
Nasopharyngitis
8%
Respiratory tract infection
6%
Depression
6%
Pulmonary hypertension
6%
Presyncope
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
4%
Anaemia
2%
Hypertension
2%
Cough
2%
Acute coronary syndrome
2%
Inguinal hernia
2%
Asthenia
2%
Cardiovascular disorder
2%
Mitral valve incompetence
2%
Gangrene
2%
Respiratory syncytial virus infection
2%
Urinary tract infection
2%
Walking distance test abnormal
2%
Breast cancer
2%
Uterine haemorrhage
2%
Haemoptysis
2%
Hypoxia
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Death
2%
General physical health deterioration
2%
Circulatory collapse
2%
Cardiac failure
2%
Coronary artery disease
2%
Chest discomfort
2%
Pancreatic neoplasm
2%
Haemoglobin decreased
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

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
4,582 Previous Clinical Trials
14,634,773 Total Patients Enrolled
20 Trials studying Heart Failure
7,201 Patients Enrolled for Heart Failure
University of CalgaryLead Sponsor
795 Previous Clinical Trials
874,555 Total Patients Enrolled
13 Trials studying Heart Failure
6,362 Patients Enrolled for Heart Failure
Jonathan Howlett, FRCPCPrincipal InvestigatorUniversity of Calgary
~3 spots leftby Jun 2025
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