Heart Failure,Phase 2/3NCT01580553
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
A Phase 2/3 study testing Levocarnitine Injection in people with Heart Failure,, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure. A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed. Treatment period: 7 days, follow-up: 1 month Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure,
- What is being tested?
- Levocarnitine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Mar 2012
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject aged ≥ 18 years, men or women.
- The subject has a diagnosis of chronic left heart or right heart failure (a past medical history of left heart failure caused by coronary heart disease, hypertension and dilated cardiomyopathy, or a medical history of right heart failure caused by pulmonary artery hypertension (the 1st type of diagnostic classification, WHO conference, Venice, 2003) and left heart disease (the 2nd type) ;the case number of right heart failure is about 30% of the total case number).
- The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
- NYHA-FC is Class II- IV (Class II cases < 20%, except the refractory terminal heart failure patients).
- The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
- CI < 2.5 L/min/m2 or CO < 4L/min (right heart failure)
- The subject has signed the ICF.
Who cannot join
- Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
- Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
- Subjects will leave the hospital in 7 days.
- Subjects with severe cerebral apoplexy (life threatening).
- Subjects with AMI or acute pulmonary embolism.
- Subjects with uremia and did not undergo dialysis.
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- Subjects with COPD.
- Subjects with severe anemia (Hb≤60g/l).
- Subject who is receiving other metabolism improving drugs within one month (such as trimetazidine dihydrochloride tablets and 1, 6- fructose diphosphate.
- Subject with other severe disease and his/her life expectancy <12 months.
- Subject who has participated in other clinical trial within 3 months or is participating in other study.
- Subject who has received L-carnitine treatment within 1 month.
- Subject who is allergic to L-carnitine and its derivatives.
- Subject is receiving other cardiotoxic drugs.
- Subjects with medical history of epilepsy.
- Subject who is a drug or alcohol abuser.
- Subject who has received PCI, CABG or vascular remodeling.
- Subject with arrhythmia that the investigator thinks unsuitable to include.
- The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
- The subject has not signed the ICF.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pulmonary Hospital affiliated to Tongji University
Shanghai, 200433
About this study
Official title: The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure -A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.
Treatment period: 7 days, follow-up: 1 month
Read the detailed description
The primary objective of this study is to assess the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
- Conditions
- Heart Failure,
- Being tested
- Levocarnitine Injection, Levocarnitine placebo
- Keywords
- Heart failure, L-carnitine, injection, safety, efficacy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocarnitine InjectionDrug
Levocarnitine Injection:5ml:1g
Levocarnitine placeboDrug
L-Carnitine injection placebo (5ml:1g)
| Study group | Role | What they receive |
|---|---|---|
| Levocarnitine | Placebo comparator | Not described Receives: Drug: Levocarnitine placebo |
| L-carnitine | Active comparator | Not described Receives: Drug: Levocarnitine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYHA cardiac functional grading
The cardiac functional changes between the end of medication (within 24 hrs) and baseline (prior to medication) are evaluated by the three-grade criteria (excellent, effective and no response). And calculate the effective rate.
Excellent: cardiac function improved for 2 grades and above Effective: cardiac function improved for one grade No response: failed to achieve the effective criteria.
Measured: 7 days treatment
Secondary outcomes (5)
Other efficacy evaluations
6-Minute Walk Test (6MWT)
Measured: 7 days treatment
Other efficacy evaluations
2.Incidence of major cardiovascular events when follow-up (within 1 month)
- symptoms get worse (NYHA cardiac functional grading aggravates)
- increase dosage or other treatment for aggravating heart failure
- need hospitalization again for heart failure or other reasons
- death
Measured: 7 days treatment
Other efficacy evaluations
Plasma L-carnitine level (acyl-carnitine/free carnitine)
Measured: 7 days treatment
Other efficacy evaluations
ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)
Measured: 7 days treatment
Other efficacy evaluations
measure the N-Terminal-pro brain natriuretic peptide level in serum
Measured: 7 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure,Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580553
- Sponsor's protocol ID
- LeesPharm_LC-HF
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure -A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01580553
- Acronym / sponsor ID
- LeesPharm_LC-HF
- Conditions
- Heart Failure,
- Keywords
- Heart failure, L-carnitine, injection, safety, efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Apr 2012 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.
Treatment period: 7 days, follow-up: 1 month
Detailed description
The primary objective of this study is to assess the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levocarnitine | Placebo comparator | Drug: Levocarnitine placebo |
| L-carnitine | Active comparator | Drug: Levocarnitine Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject aged ≥ 18 years, men or women.
- The subject has a diagnosis of chronic left heart or right heart failure (a past medical history of left heart failure caused by coronary heart disease, hypertension and dilated cardiomyopathy, or a medical history of right heart failure caused by pulmonary artery hypertension (the 1st type of diagnostic classification, WHO conference, Venice, 2003) and left heart disease (the 2nd type) ;the case number of right heart failure is about 30% of the total case number).
- The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
- NYHA-FC is Class II- IV (Class II cases < 20%, except the refractory terminal heart failure patients).
- The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
Key exclusion criteria (20 listed)
- Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
- Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
- Subjects will leave the hospital in 7 days.
- Subjects with severe cerebral apoplexy (life threatening).
- Subjects with AMI or acute pulmonary embolism.
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 |
|---|---|---|
| Levocarnitine InjectionLevocarnitine Injection:5ml:1g | Drug | L-carnitine |
| Levocarnitine placeboL-Carnitine injection placebo (5ml:1g) | Drug | Levocarnitine |
Primary outcome
NYHA cardiac functional grading
Time frame: 7 days treatment
The cardiac functional changes between the end of medication (within 24 hrs) and baseline (prior to medication) are evaluated by the three-grade criteria (excellent, effective and no response). And calculate the effective rate. Excellent: cardiac function improved for 2 grades and above Effective: cardiac function improved for one grade No response: failed to achieve the effective criteria.
5 secondary outcomes
Other efficacy evaluations
Time frame: 7 days treatment
Other efficacy evaluations
Time frame: 7 days treatment
Other efficacy evaluations
Time frame: 7 days treatment
Other efficacy evaluations
Time frame: 7 days treatment
Other efficacy evaluations
Time frame: 7 days treatment
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 27 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levocarnitine Injection in people with Heart Failure,, run by Lee's Pharmaceutical Limited at 1 site in China.
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 7 inclusion and 20 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 27 Apr 2012. 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 China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
NYHA cardiac functional grading (time frame: 7 days treatment). 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 27 Apr 2012.