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

Sponsor
Cardiora Pty. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03217331
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
14.8
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Actual Study Start Date :
Mar 6, 2018
Actual Primary Completion Date :
Oct 10, 2018
Actual Study Completion Date :
May 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: CRD-102 Treatment

CRD102 Treatment

Drug: CRD-102
14 mg CRD-102 capsules administered twice daily orally for 14 days.

Outcome Measures

Primary Outcome Measures

  1. Safety: Subject incidence of adverse events [40 days]

    Number of adverse events as a measure of safety and tolerability.

Other Outcome Measures

  1. Exploratory: Pulmonary artery pressures (mmHg). [40 days]

    Changes compared to baseline in Pulmonary artery pressures (mmHg)

  2. Exploratory: Left ventricular ejection fraction (%) [40 days]

    Changes compared to baseline in left ventricular ejection fraction (%)

  3. Exploratory: Quality of life (KCCQ questionnaire) [40 days]

    Changes compared to baseline in Quality of life (KCCQ questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients are enrolled only if they met the following criteria.

  1. Males and females aged 18-85 years inclusive

  2. Have received a LVAD (HeartWare HVAD, HeartMate II) at least 30 days prior to screening.

  3. 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;

  4. ongoing diuretic therapy;

  5. 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.

  6. Able to give written informed consent and agree to adhere to all protocol requirements.

  7. All patients will be required to have an implanted cardiaoverter defibrillator. (ICD)

Exclusion Criteria:

  1. Hemodynamically unstable patients.

  2. Hypotension (MAP<60 or systolic BP <90 mmHg) at Screening or Baseline

  3. Hypertension (MAP>95 or systolic BP >130 mmHg) at Screening or Baseline

  4. Ventricular tachycardia or ventricular fibrillation in the past 30 days or poorly controlled atrial fibrillation (ventricular rate >120 bpm)

  5. Concurrent participation in another investigational device study or prior participation in which a device was implanted and remains in place

  6. Receipt of any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to Baseline.

  7. Current treatment with intravenous inotropes or levosimendan, or treatment within the 2 weeks prior to Screening

  8. 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.

  9. Expected heart transplantation within the study period.

  10. Pregnancy

  11. History of allergic reaction to milrinone or any excipients in the study drug.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Chicago Medical Center Chicago Illinois United States 60637

Sponsors and Collaborators

  • Cardiora Pty. Ltd.

Investigators

  • Study Chair: David Kaye, MD PhD, Cardiora Pty. Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiora Pty. Ltd.
ClinicalTrials.gov Identifier:
NCT03217331
Other Study ID Numbers:
  • CARD-LV01
First Posted:
Jul 14, 2017
Last Update Posted:
Jun 25, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jun 25, 2019