Right Heart FailurePhase 1/2NCT03217331
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
A Phase 1/2 study testing CRD-102 in people with Right Heart Failure and Left Ventricular Assist Device, run by Cardiora Pty. Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Right Heart Failure, Left Ventricular Assist Device
- What is being tested?
- CRD-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 30 May 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
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.
- Being tested
- CRD-102
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD-102Drug
14 mg CRD-102 capsules administered twice daily orally for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| CRD-102 Treatment | Experimental | CRD102 Treatment Receives: Drug: CRD-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Subject incidence of adverse events
Number of adverse events as a measure of safety and tolerability.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start6 Mar 2018
- Primary completion10 Oct 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiora Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kaye, MD PhD, Study chair, Cardiora Pty. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217331
- Sponsor's protocol ID
- CARD-LV01
- Status last verified
- Jun 2019
- First submitted
- 5 Jul 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT03217331
- Acronym / sponsor ID
- CARD-LV01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cardiora Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRD-102 Treatment | Experimental | Drug: CRD-102CRD102 Treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Able to give written informed consent and agree to adhere to all protocol requirements.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD-10214 mg CRD-102 capsules administered twice daily orally for 14 days. | Drug | CRD-102 Treatment |
Primary outcome
Safety: Subject incidence of adverse events
Time frame: 40 days
Number of adverse events as a measure of safety and tolerability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kaye, MD PhD study chair
Cardiora Pty. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRD-102 in people with Right Heart Failure and Left Ventricular Assist Device, run by Cardiora Pty. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Subject incidence of adverse events (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.