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Left Ventricular Pressure as a Treatment Target in Patients with Myocardial Infarction.

Effect of Nitrates and Frusemide on Left Ventricular Pressure in Patients with ST-Segment Elevation Myocardial Infarction Following Primary Percutaneous Coronary Intervention.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000368336
Acronym
LVEDP
Enrollment
10
Registered
2017-03-10
Start date
2017-04-03
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

None listed

Brief summary

For this acute hemodynamic study, we will measure pressure within the main pumping chamber of the heart (the left ventricle) with a plastic tube (called catheter) after treating the heart attack. In the intervention group, we will give increasing doses of a medication (Glyceryl trinitrate) through the drip for 10 minutes if there are no contraindications or concerns and will simultaneously measure the pressure within the main pumping chamber. Patients will also be given 40 mg of a fluid medication (frusemide). In the control group, pressure in the main pumping chamber will be measured for 10 minutes but no trial medication will be administered. The aim of this study is to find a dose of these medications that will reduce pressure within the main pumping chamber of the heart without affecting blood pressure or causing any side effects. These medications are routinely used during all the angiography and stenting procedures but have never been used to reduce the pressure within the heart.

Interventions

There is observational evidence that patients with high left ventricular end diastolic pressure (LVEDP) post ST-segment elevation myocardial infarction (STEMI) have higher mortality and re-admission rates but there are no prospective studies that have targeted LVEDP reduction after opening the infarct related artery. In order to design a prospective trial with LVEDP as the treatment target, dose of nitrates needs to be calculated that can cause a reasonable reduction in LVEDP without causing a s

There is observational evidence that patients with high left ventricular end diastolic pressure (LVEDP) post ST-segment elevation myocardial infarction (STEMI) have higher mortality and re-admission rates but there are no prospective studies that have targeted LVEDP reduction after opening the infarct related artery. In order to design a prospective trial with LVEDP as the treatment target, dose of nitrates needs to be calculated that can cause a reasonable reduction in LVEDP without causing a significant drop in the systemic blood pressure. Thus, the aim of this acute hemodynamic study is to find a dose of nitrate in conjunction with a single bolus of frusemide that reduces LVEDP without causing symptomatic drop in the systemic blood pressure. We aim to enroll 20 patients in our study (Intervention group=10, Control group=10). All patients will have left heart catheterization performed and LVEDP measured immediately after primary percutaneous coronary intervention (PCI) as is standard practice in our institution. Patients with LVEDP greater than 20 mmHg will be enrolled to our study. The patients in the intervention arm will have intravenous administration of frusemide 40mg bolus plus escalating doses of IV glyceryl trinitrate (GTN) during simultaneous measurement of pressure in their left ventricular cavity. We will administer 100mcg GTN intravenously and administer further 100mcg boluses each minute to a maximum of 1000mcg. The study will terminate when there is a drop in either arterial pressure or LVEDP by 20% or if 1000 mcg is reached (over 10 mins) without any demonstrable effect on LVEDP or systemic blood pressure. We will also perform echocardiogram simultaneously and measure mitral inflow pulse wave Doppler, mitral annular velocities (E/E' ratios), pulmonary venous pulse wave Doppler and pulmonary artery systolic pressures at baseline and after the last dose of GTN.

Sponsors

Cardiovascular Department John Hunter Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1- Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. 2- Left ventricular end diastolic pressure > 20 mmHg. 3- Systemic blood pressure > 100 mmHg. 4- No known hypersensitivity or adverse reaction to nitrates or frusemide.

Exclusion criteria

1- Age < 18 years. 2- Cardiogenic shock. 3- Electrical instability requiring intervention. 4- Coronary revascularisation not performed. 5- Pulmonary oedema requiring open label diuretics or nitrates. 6- Renal impairment requiring dialysis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026