CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Completed · Phase 1/Phase 2
Conditions studied: Right Heart Failure, Left Ventricular Assist Device
In brief
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
Key facts
- Study ID
- NCT03217331
- Run by
- Cardiora Pty. Ltd.
- People needed
- 6
- Starts
- 2018-03-06
- Expected to finish
- 2019-05-30
- Last updated by the study team
- 2019-06-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- The University of Chicago Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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