CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices

The study will be conducted over a 40 day time period inclusive of screening and follow up time periods. Eligible subjects will receive oral CRD-102 for 14 days.

Inclusion criteria

Patients are enrolled only if they met the following criteria.

• Males and females aged 18-85 years inclusive
• Have received a LVAD (HeartWare HVAD, HeartMate II) at least 30 days prior to screening.
• Stable LVAD patients with evidence of ongoing right heart failure as evidenced by raised right atrial pressure indicated by JVP >6cm OR measured right atrial pressure ≥12mmHg within the 3 months prior to or at Baseline OR dilated IVC on echocardiography PLUS all of the following;

• ongoing diuretic therapy;
• echocardiography in the 3 months prior to or at Baseline showing at least mild impairment in overall RV systolic function by visual assessment together with a TAPSE < 14mm.
• Able to give written informed consent and agree to adhere to all protocol requirements.
• All patients will be required to have an implanted cardiaoverter defibrillator. (ICD)

Exclusion criteria

• Hemodynamically unstable patients.
• Hypotension (MAP<60 or systolic BP <90 mmHg) at Screening or Baseline
• Hypertension (MAP>95 or systolic BP >130 mmHg) at Screening or Baseline
• Ventricular tachycardia or ventricular fibrillation in the past 30 days or poorly controlled atrial fibrillation (ventricular rate >120 bpm)
• Concurrent participation in another investigational device study or prior participation in which a device was implanted and remains in place
• Receipt of any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to Baseline.
• Current treatment with intravenous inotropes or levosimendan, or treatment within the 2 weeks prior to Screening
• Significant renal (eGFR<25 ml/min/1.73 sq m) or hepatic (bilirubin >3mg/dL) impairment or anemia (Hb <90g/dL) at Screening or Baseline.
• Expected heart transplantation within the study period.
• Pregnancy
• History of allergic reaction to milrinone or any excipients in the study drug.