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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD-102 Treatment | Experimental | CRD102 Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRD-102 | Drug | 14 mg CRD-102 capsules administered twice daily orally for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Subject incidence of adverse events | Number of adverse events as a measure of safety and tolerability. | 40 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Pulmonary artery pressures (mmHg). | Changes compared to baseline in Pulmonary artery pressures (mmHg) | 40 days |
| Exploratory: Left ventricular ejection fraction (%) | Changes compared to baseline in left ventricular ejection fraction (%) |
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;
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Kaye, MD PhD | Cardiora Pty. Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 40 days |
| Exploratory: Quality of life (KCCQ questionnaire) | Changes compared to baseline in Quality of life (KCCQ questionnaire) | 40 days |