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

Right Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217331
• Other study ID #: CARD-LV01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 6, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: June 2019
• Source: Cardiora Pty. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 30, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Assist Device
• Right Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cardiora Pty. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Pulmonary artery pressures (mmHg).	Changes compared to baseline in Pulmonary artery pressures (mmHg)	40 days
Other	Exploratory: Left ventricular ejection fraction (%)	Changes compared to baseline in left ventricular ejection fraction (%)	40 days
Other	Exploratory: Quality of life (KCCQ questionnaire)	Changes compared to baseline in Quality of life (KCCQ questionnaire)	40 days
Primary	Safety: Subject incidence of adverse events	Number of adverse events as a measure of safety and tolerability.	40 days