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

NCT03217331 | Completed Phase 1 FDA Drug

• 1 other identifier: CARD-LV01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Heart Failure; Left Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Safety: Subject incidence of adverse events

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

  40 days

Other Outcomes (3)

• Exploratory: Pulmonary artery pressures (mmHg).

  40 days

• Exploratory: Left ventricular ejection fraction (%)

  40 days

• Exploratory: Quality of life (KCCQ questionnaire)

  40 days

Study Arms (1)

CRD-102 Treatment

EXPERIMENTAL

CRD102 Treatment

Drug: CRD-102

Interventions

CRD-102 DRUG

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

CRD-102 Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiora Pty. Ltd.: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David Kaye, MD PhD

  Cardiora Pty. Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 14, 2017
• Study Start: March 6, 2018
• Primary Completion: October 10, 2018
• Study Completion: May 30, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)