Chronic Heart FailurePhase 4NCT03344523
Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron Deficiency
A Phase 4 study testing Iron protein succinylate oral solution and standard treatment in people with Chronic Heart Failure and Iron-deficiency, run by Lee's Pharmaceutical Limited.
Trial summary
This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Iron-deficiency
- What is being tested?
- Iron protein succinylate oral solution and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Dec 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form;
- Between 18 to 80 years old, male or female;
- Patients with chronic ejection fraction reduction heart failure, has been accepted the medication recommended by the Guidelines for treatment of heart failure in China (2014) for at least 4 weeks (that comply with the following requirements): if there is no contraindications or intolerance, patients should receive the renin angiotensin aldosterone system inhibitors, B blockers, and no dose adjustment within 4 weeks (not including diuretics). For patients who do not follow the guidelines for the use and titration of the renin angiotensin aldosterone system inhibitor and B blocker drugs, the cause should be recorded;
- LVEF< 40% (determined by Simpson method) (valid for one week before randomization);
- NYHA heart function II-III Grade;
- NT-proBNP>400pg/ml, it should be .900pg/ml at atrial fibrillation;
- Upper limit of hemoglobin: women less than 120g/L, men less than 130g/L. Lower limit of hemoglobin: more than 90g/L for both men and women. Accompanied by Iron deficiency (iron deficiency is defined as serum ferritin<100ug/L, or serum ferritin between 100~300ug/L with transferrin saturation (Tsat) <20%);
- Capable of 6 Minute walk test.
Who cannot join
- Patients with significant bleeding: gastrointestinal bleeding, menorrhagia, history of gastrointestinal bleeding and no evidence of gastrointestinal disease healing;
- History of oral iron supplementation and intolerance;
- History of acquired iron overload;
- Exclude if receiving erythropoietin, intravenous iron, transfusion therapy and oral iron (including iron contained in compound vitamins or other compound medicine) ≧75mg/day within 6 weeks before enrollment;
- Patients in urgent need of blood transfusion;
- VtaminB12 and/or folate deficiency, unless correctable; and Non-iron deficiency anemia;
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- Severe renal insufficiency（eGFR < 20ml/min/1.73m2, MDRD formula）, renal anemia; or history of kidney dialysis, need of kidney dialysis at present or in 6 months;
- Chronic liver disease, cirrhosis, active hepatitis, transaminases (increase of alanine aminotransferase and aspartate aminotransferase 3 times above the normal upper limit. Total bilirubin 3 times higher than the normal upper limit);
- Intestinal diseases which affect iron absorption such as inflammatory bowel disease and chronic pancreatitis;
- Active infection;
- History of syncope within 3 months, diagnosed as cardiogenic shock over the past 1 months;
- Active myocarditis, constrictive pericarditis and other pericardial diseases;
- Acute decompensated heart failure with unstable hemodynamics;
- Symptomatic bradycardia or second or third-degree cardiac conduction block with no pacemaker installed;
- Severe chronic obstructive pulmonary disease, pulmonary heart disease, severe pulmonary vascular disease, pulmonary hypertension caused by autoimmune diseases and any type of severe pulmonary hypertension;
- Valvular heart disease and congenital heart disease without operation; hypertrophic cardiomyopathy, restricted cardiomyopathy, and other secondary cardiomyopathy;
- Patients with malignancy;
- Patients combined with other organ diseases such as hematopoietic system, nervous system, endocrine system like thyroid, and combined with psychosis;
- There is uncontrolled hypertension, systolic pressure is greater than 180mmHg and/or diastolic pressure is greater than 110mmHg;
- Heart rate ≥ 130 times/minute before randomization, or malignant ventricular arrhythmia affecting hemodynamic;
- Neuromuscular disease, disability or other non-cardiac causes influencing the performance of 6 Minute walk test;
- Occurred within 3 months: acute coronary syndrome, stroke, transient cerebral ischemic attack; cardiac, carotid artery or other major vascular surgery; percutaneous coronary intervention (PCI) or carotid artery angioplasty or coronary bypass surgery and other cardiac surgery; or scheduled for percutaneous intervention and surgery surgical treatment within 6 months;
- Has been implanted pacemaker/defibrillator (CRT-P/D) of cardiac resynchronization therapy within 6 months, or the intention to implant a similar device within 6 months after randomization;
- Has been received major surgery within 6 months prior to randomization, or intend to receive major surgical treatment within 6 months;
- History of heart transplantation or waiting for transplantation or using a left ventricular assist device (LVAD) or a heart transplant intention (waiting for transplantation) or intend to use VAD over the next 6 months;
- Nursing or pregnant women, or women of childbearing age without contraception, or patients planned pregnancy in 6 months;
- History of major organ transplant (such as lung, liver, bone marrow, kidney)
- Patients have been involved or to be involved in other clinical trials within one month;
- Patients cannot understand the informed consent form or cannot make decisions or of poor compliance;
- Patients judged as unsuitable for the study and life expectancy less than 1 year by investigators.
About this study
Official title: A Randomized, Double-blind, Multi-center Clinical Trial Prospectively Evaluating Iron Protein Succinylate Oral Solution in Treating Patients With Chronic Heart Failure and Iron Deficiency
This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency.
Read the detailed description
This clinical trial was designed as a multicenter, prospective, randomized, double-blind controlled study. Patients were randomly divided into one of two treatment groups:
Control group: standard treatment + placebo（1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Test group: standard treatment + Iron protein succinylate oral solution (1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Sample size calculation is according to the change of 6 Minute walk distance from the baseline at 24 weeks, it is estimated the mean difference between two groups is 20 meter, standard deviation 80 meter, statistical power 80%, type I error 0.05, follow up loss 15%，estimated total sample size 600.
- Conditions
- Chronic Heart Failure, Iron-deficiency
- Being tested
- Iron protein succinylate oral solution, standard treatment
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron protein succinylate oral solutionDrug
Iron protein succinylate oral solution
standard treatmentOther
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| standard treatment + Iron succinylate | Experimental | 1 bottle orally, twice daily, take orally before meals Receives: Drug: Iron protein succinylate oral solution; Other: standard treatment |
| standard treatment + placebo | Placebo comparator | 1 bottle orally, twice daily, take orally before meals Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 6 Minute walk distances
The change of 6 Minute walk distances compared to baseline after patients receiving 24 week treatment.
Measured: 24 week
Secondary outcomes (8)
Variety of overall status score（PGA）after patients receiving 24 week treatment
Measured: 24 week
Kansas City Cardiomyopathy Questionnaire (KCCQ) rating change after patients receiving 24 week treatment
Measured: 24 week
Change of 6 Minute walk distance after patients receiving 16 week treatment
Measured: 16 week
Change of blood NT-proBNP after patients receiving 24 week treatment
Measured: 24 week
Cardiovascular death or heart failure re-hospitalization after patients receiving 24 week treatment
Measured: 24 week
Comprehensive cause mortality after patients receiving 52 week treatment
Measured: 24 week
EQ-5D Questionnaire score after patients receiving 24 week treatment
Measured: 24 week
Change of NYHA grading after patients receiving 24 weeks treatment
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
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
- NCT03344523
- Sponsor's protocol ID
- 2016-ZX02
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center Clinical Trial Prospectively Evaluating Iron Protein Succinylate Oral Solution in Treating Patients With Chronic Heart Failure and Iron Deficiency
- ClinicalTrials.gov ID
- NCT03344523
- Acronym / sponsor ID
- 2016-ZX02
- Conditions
- Chronic Heart Failure, Iron-deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Nov 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 study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency.
Detailed description
This clinical trial was designed as a multicenter, prospective, randomized, double-blind controlled study. Patients were randomly divided into one of two treatment groups:
Control group: standard treatment + placebo（1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Test group: standard treatment + Iron protein succinylate oral solution (1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Sample size calculation is according to the change of 6 Minute walk distance from the baseline at 24 weeks, it is estimated the mean difference between two groups is 20 meter, standard deviation 80 meter, statistical power 80%, type I error 0.05, follow up loss 15%，estimated total sample size 600.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment + Iron succinylate | Experimental | Drug: Iron protein succinylate oral solution, Other: standard treatment1 bottle orally, twice daily, take orally before meals |
| standard treatment + placebo | Placebo comparator | Other: standard treatment1 bottle orally, twice daily, take orally before meals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sign informed consent form;
- Between 18 to 80 years old, male or female;
- Patients with chronic ejection fraction reduction heart failure, has been accepted the medication recommended by the Guidelines for treatment of heart failure in China (2014) for at least 4 weeks (that comply with the following requirements): if there is no contraindications or intolerance, patients should receive the renin angiotensin aldosterone system inhibitors, B blockers, and no dose adjustment within 4 weeks (not including diuretics). For patients who do not follow the guidelines for the use and titration of the renin angiotensin aldosterone system inhibitor and B blocker drugs, the cause should be recorded;
- LVEF< 40% (determined by Simpson method) (valid for one week before randomization);
- NYHA heart function II-III Grade;
Key exclusion criteria (30 listed)
- Patients with significant bleeding: gastrointestinal bleeding, menorrhagia, history of gastrointestinal bleeding and no evidence of gastrointestinal disease healing;
- History of oral iron supplementation and intolerance;
- History of acquired iron overload;
- Exclude if receiving erythropoietin, intravenous iron, transfusion therapy and oral iron (including iron contained in compound vitamins or other compound medicine) ≧75mg/day within 6 weeks before enrollment;
- Patients in urgent need of blood transfusion;
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 |
|---|---|---|
| Iron protein succinylate oral solutionIron protein succinylate oral solution | Drug | standard treatment + Iron succinylate |
| standard treatmentstandard treatment | Other | standard treatment + Iron succinylate, standard treatment + placebo |
Primary outcome
The change of 6 Minute walk distances
Time frame: 24 week
The change of 6 Minute walk distances compared to baseline after patients receiving 24 week treatment.
8 secondary outcomes
Variety of overall status score（PGA）after patients receiving 24 week treatment
Time frame: 24 week
Kansas City Cardiomyopathy Questionnaire (KCCQ) rating change after patients receiving 24 week treatment
Time frame: 24 week
Change of 6 Minute walk distance after patients receiving 16 week treatment
Time frame: 16 week
Change of blood NT-proBNP after patients receiving 24 week treatment
Time frame: 24 week
Cardiovascular death or heart failure re-hospitalization after patients receiving 24 week treatment
Time frame: 24 week
Comprehensive cause mortality after patients receiving 52 week treatment
Time frame: 24 week
EQ-5D Questionnaire score after patients receiving 24 week treatment
Time frame: 24 week
Change of NYHA grading after patients receiving 24 weeks treatment
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron protein succinylate oral solution and standard treatment in people with Chronic Heart Failure and Iron-deficiency, run by Lee's Pharmaceutical Limited.
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 30 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 17 Nov 2017. 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. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
The change of 6 Minute walk distances (time frame: 24 week). 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 17 Nov 2017.