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

NCT ID: NCT03217331

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2019-05-30

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.

Conditions

Right Heart Failure; Left Ventricular Assist Device

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRD-102 Treatment

CRD102 Treatment

Group Type: EXPERIMENTAL

CRD-102

Intervention Type: DRUG

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

Interventions

CRD-102

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

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiora Pty. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kaye, MD PhD

Role: STUDY_CHAIR

Cardiora Pty. Ltd.

Locations

The University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CARD-LV01

Identifier Type: -

Identifier Source: org_study_id