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CompletedNCT03217331Updated Jun 25, 2019

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

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

From the registry’s dates

  • Primary completion was Oct 2018, 7 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Right Heart Failure
  • Left Ventricular Assist Device

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03

In context

Heart Failure

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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;

    1. ongoing diuretic therapy;
    2. 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.
  4. Able to give written informed consent and agree to adhere to all protocol requirements.
  5. All patients will be required to have an implanted cardiaoverter defibrillator. (ICD)

Exclusion criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    CRD-102 Treatment

    CRD102 Treatment

    Drug: CRD-102

Interventions

  • DrugCRD-102

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

06

What researchers measure

Primary outcomes

  1. Safety: Subject incidence of adverse events

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

    Time frame: 40 days

Other outcomes

  1. Exploratory: Pulmonary artery pressures (mmHg).

    Changes compared to baseline in Pulmonary artery pressures (mmHg)

    Time frame: 40 days

  2. Exploratory: Left ventricular ejection fraction (%)

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

    Time frame: 40 days

  3. Exploratory: Quality of life (KCCQ questionnaire)

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

    Time frame: 40 days

07

Study locations

1 site
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03217331
Lead sponsor
Cardiora Pty. Ltd.
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Mar 6, 2018
Primary completion
Oct 10, 2018
Completion
May 30, 2019
Last update
Jun 25, 2019

Study contacts

David Kaye, MD PhD
study chair · Cardiora Pty. Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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