Back to resultsCRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Primary Purpose
Right Heart Failure, Left Ventricular Assist Device
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CRD-102
Sponsored by
About this trial
This is an interventional treatment trial for Right Heart Failure
Eligibility Criteria
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.
Sites / Locations
- The University of Chicago Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRD-102 Treatment
Arm Description
CRD102 Treatment
Outcomes
Primary Outcome Measures
Safety: Subject incidence of adverse events
Number of adverse events as a measure of safety and tolerability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03217331
Brief Title
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Official Title
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiora Pty. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Failure, Left Ventricular Assist Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRD-102 Treatment
Arm Type
Experimental
Arm Description
CRD102 Treatment
Intervention Type
Drug
Intervention Name(s)
CRD-102
Intervention Description
14 mg CRD-102 capsules administered twice daily orally for 14 days.
Primary Outcome Measure Information:
Title
Safety: Subject incidence of adverse events
Description
Number of adverse events as a measure of safety and tolerability.
Time Frame
40 days
Other Pre-specified Outcome Measures:
Title
Exploratory: Pulmonary artery pressures (mmHg).
Description
Changes compared to baseline in Pulmonary artery pressures (mmHg)
Time Frame
40 days
Title
Exploratory: Left ventricular ejection fraction (%)
Description
Changes compared to baseline in left ventricular ejection fraction (%)
Time Frame
40 days
Title
Exploratory: Quality of life (KCCQ questionnaire)
Description
Changes compared to baseline in Quality of life (KCCQ questionnaire)
Time Frame
40 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kaye, MD PhD
Organizational Affiliation
Cardiora Pty. Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
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