Effect of preoperative sildenafil on patients with severe pulmonary hypertension undergoing heart valve replacement.

Observational study of the effects of preoperative Sildenafil on patients with pulmonary hypertension and valvular heart disease undergoing valve replacement surgery; To determine whether sildenfil reduces pulmonary pressures and examine whether this has any clinical significance in terms of morbidity and mortality

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000267954

Enrollment

Registered

2011-03-11

Start date

2011-03-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sildenafil is a drug that can be used to treat raised blood pressure within the lungs. In patients undergoing valvular heart surgery who also have high pressure, it is thought that it may reduce the risk of the right side of the heart from stopping working properly. In addition there is also evidence that it may reduce time on a ventilator in ICU. There have been several studies in heart transplants and congenital heart disease that have shown some advantage. We want to ascertain whether the theoretical advantages of the drug are actually borne out in clinical practice

Interventions

Observation of changes in cardiorespiratory parameters over the course of valve replacement surgery in patients with severe pulmonary hypertension. Patients were were given oral tablet of sildenafil 25mg three times per day in the 48 hour preoperative period in order to reduce pulmonary pressures prior to surgery. The initial observational period will be one year.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing valve replacement surgery who have concurrent severe pulmonary hypertension (>50mmHg or > 40mmHg with evidence of right ventricular failure)

Exclusion criteria

There are no exclusion criteria as all patients who meet the inclusion criteria will be included in this observational study.

Outcome results