A Phase 1/2 interventional study of CRD-102 in Right Heart Failure and Left Ventricular Assist Device, sponsored by Cardiora Pty. Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Cardiora Pty. Ltd. · Phase 1/2, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Cardiora Pty. Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients are enrolled only if they met the following criteria.
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;
Exclusion Criteria:
CRD102 Treatment
Drug: CRD-102
14 mg CRD-102 capsules administered twice daily orally for 14 days.
Safety: Subject incidence of adverse events
Number of adverse events as a measure of safety and tolerability.
Time frame: 40 days
Exploratory: Pulmonary artery pressures (mmHg).
Changes compared to baseline in Pulmonary artery pressures (mmHg)
Time frame: 40 days
Exploratory: Left ventricular ejection fraction (%)
Changes compared to baseline in left ventricular ejection fraction (%)
Time frame: 40 days
Exploratory: Quality of life (KCCQ questionnaire)
Changes compared to baseline in Quality of life (KCCQ questionnaire)
Time frame: 40 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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