Heart FailurePhase 1CAPITAL-ACNCT03634189
Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C
A Phase 1 study testing Cannabidiol in people with Heart Failure, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud.
Trial summary
Cannabidiol in heart failure Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Dec 2021
- Phase
- Phase 1
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (women not pregnant neither in lactation period) between 30 to 75 years-old
- Patients with stage A-C of the American College of Cardiology/American Heart Association classification
- Patients with GDMT and clinical stability within four weeks
- Diagnosis of ischemic or non-ischemic dilated cardiomyopathy
- Participants should sign an informed consent form (ICF) form personally
Who cannot join
- Severe primary valvular cardiomyopathy or valvular prosthesis (mechanical or bio-valve)
- History of heart transplant surgery, cardiomyoplasty, left ventricular reduction surgery, valvuloplasty, implantation of a ventricle assist device and surgical cardiac congenital defect correction
- Implantable cardioverter defibrillator within the last three months
- Acute coronary syndromes that required pharmacological or mechanical reperfusion or medical treatment, within 30 days before selection
- Percutaneous coronary intervention within 30 days prior to selection
- Women who are pregnant, or of childbearing potential and are not practicing an effective means of birth control
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- Untreated thyroid disease
- Hepatorenal syndrome
- History of seizures
- Hemoglobin: < 8.5 gm/dL
- WBC count lower than 3000/mm3
- Platelets: <100,000/mm
- AST or ALT >2.5 × upper limit of normal (ULN) unless related to primary disease
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Active cancer of any etiology
- History of psychiatric disorder (depression or PHQ-9 ≥ 10 points , bipolar syndrome, schizophrenia) or suicide attempt.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Fertile female participants not applying any approved duel anti-contraceptive method
- Inability to comply/assist with study and follow-up procedures
- Patients in cardiovascular rehabilitation programs
- Any person who is not able to give adequate ICF
- Elimination criteria
- Progression of heart failure stage according to the American College of Cardiology/American Heart Association classification, since the initiation of the study.
- ALT or AST >3x normal values with a total bilirubin ≥ 2x normal value.
- Any degree of depression at any stage of the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C
Cannabidiol in heart failure
- Conditions
- Heart Failure
- Being tested
- Cannabidiol
- Keywords
- Cannabidiol, Heart Failure, AHA/ACC stage A-C
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Patients with ACC/AHA stage A-C will receive 5 mg/kg to a maximum tolerated dose of 25 mg/kg PO BID of Cannabidiol
| Study group | Role | What they receive |
|---|---|---|
| HF- ACC/AHA stage A-C + CBD | Experimental | Patients with HF stages A-C + Cannabidiol Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1
We will assess the safety of CBD in patients with HF ACC/AHA stages A-C based on the incidence of events of interest and serious adverse events. This assessment will be performed at each on-site visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Mar 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rodriguez, Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634189
- Sponsor's protocol ID
- CAPITAL-AC
- Acronym
- CAPITAL-AC
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C
- ClinicalTrials.gov ID
- NCT03634189
- Acronym / sponsor ID
- CAPITAL-AC / CAPITAL-AC
- Conditions
- Heart Failure
- Keywords
- Cannabidiol, Heart Failure, AHA/ACC stage A-C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec SaludUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 16 Aug 2018 (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.
Cannabidiol in heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF- ACC/AHA stage A-C + CBD | Experimental | Drug: CannabidiolPatients with HF stages A-C + Cannabidiol |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women (women not pregnant neither in lactation period) between 30 to 75 years-old
- Patients with stage A-C of the American College of Cardiology/American Heart Association classification
- Patients with GDMT and clinical stability within four weeks
- Diagnosis of ischemic or non-ischemic dilated cardiomyopathy
- Participants should sign an informed consent form (ICF) form personally
Key exclusion criteria (25 listed)
- Severe primary valvular cardiomyopathy or valvular prosthesis (mechanical or bio-valve)
- History of heart transplant surgery, cardiomyoplasty, left ventricular reduction surgery, valvuloplasty, implantation of a ventricle assist device and surgical cardiac congenital defect correction
- Implantable cardioverter defibrillator within the last three months
- Acute coronary syndromes that required pharmacological or mechanical reperfusion or medical treatment, within 30 days before selection
- Percutaneous coronary intervention within 30 days prior to selection
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 |
|---|---|---|
| CannabidiolPatients with ACC/AHA stage A-C will receive 5 mg/kg to a maximum tolerated dose of 25 mg/kg PO BID of Cannabidiol | Drug | HF- ACC/AHA stage A-C + CBD |
Primary outcome
Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1
Time frame: 6 months
We will assess the safety of CBD in patients with HF ACC/AHA stages A-C based on the incidence of events of interest and serious adverse events. This assessment will be performed at each on-site visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol in people with Heart Failure, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud.
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 5 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Torre-Amione, MD, PhD (+52-81-8888-0500, guillermo.torre@itesm.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1 (time frame: 6 months). 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 5 Aug 2020.