Investigator Led Study of Intravenous Milrinone in Heart Failure with Preserved Ejection Fraction (HFpEF).

Phase 1

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619001171101
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Inclusion Criteria:
1.Males and females aged 18-85.
2.Symptoms of heart failure (NYHA class III or ambulatory class IV).
3.Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%.
4.Heart Failure hospitalization within 12 months or NT-proBNP greater than 125 pg/mL.
5.Evidence of prior diagnosis of HFpEF, confirmed via:
•Echocardiographic parameters (one or more of the following) observed//recorded in previous 6 months:
oseptal E/e’ greater than or equal to 13 (a measure of LV filling pressure) or
oleft atrial volume index greater than 34ml/m2 or
oLV mass index greater than or equal to 115 g/m2 (male) or greater than or equal to 95 g/m2 (female).
or
•Hemodynamic exercise test within 12 months.
6.Stable medical heart failure therapy including diuretics for 2 weeks.
7.Able to give written informed consent and agree to adhere to all protocol requirements.
8.Potassium between 4 – 5.5mmol/L

Exclusion Criteria

Exclusion Criteria:
1.Myocardial infarction or acute coronary syndromes within 90 days.
2.Hypotension (systolic BP <90 mmHg) at Screening or Baseline
3.Severe Hypertension (systolic BP >180 mmHg) at Screening or Baseline
4.Poorly controlled atrial fibrillation (ventricular rate>120bpm).
5.History of significant ventricular arrhythmia in the past year
6.Significant renal impairment (eGFR <30 ml/min/1.73 m2)
7.Severe physical limitation defined by inability to complete a minimum exercise tolerance time of 120 seconds on two treadmill tests within 2 weeks of enrollment
8.Restrictive or infiltrative cardiomyopathy.
9.Pregnancy
10.History of allergic reaction to milrinone or any excipients in the study drug.
11.Participation in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes compared to baseline (at rest, 20 W and peak supine exercise) in pulmonary capillary wedge pressure (PCWP). This analysis will be conducted utilising a swann ganz catheter during an exercise Right Heart Catheterisation in order to obtain a PCWP and snapshot the PCWP waveform. <br>[during exercise RHC (Procedure D1)];Changes compared to baseline (at rest, 20 W and peak supine exercise) in pulmonary artery pressures (mean, systolic, diastolic and pulse pressure) and derived parameters including pulmonary arterial compliance and elastance. These changes in pressures are measured in an exercise right heart cath on procedure day,<br><br>This is a composite outcome - the elements of this outcome outlined/broken down here will aid in providing one outcome on pulmonary artery pressures.[during exercise RHC (Procedure D1)];Changes compared to baseline (at rest, 20 W and peak supine exercise) in Cardiac Output (thermodilution)[during exercise RHC (Procedure D1)]