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Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron Deficiency

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ClinicalTrials.gov Identifier: NCT03344523
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Iron-deficiency Drug: Iron protein succinylate oral solution Other: standard treatment Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: standard treatment + Iron succinylate
1 bottle orally, twice daily, take orally before meals
Drug: Iron protein succinylate oral solution
Iron protein succinylate oral solution
Other: standard treatment
standard treatment
Placebo Comparator: standard treatment + placebo
1 bottle orally, twice daily, take orally before meals
Other: standard treatment
standard treatment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Variety of overall status score(PGA)after patients receiving 24 week treatment [ Time Frame: 24 week ]
  2. Kansas City Cardiomyopathy Questionnaire (KCCQ) rating change after patients receiving 24 week treatment [ Time Frame: 24 week ]
  3. Change of 6 Minute walk distance after patients receiving 16 week treatment [ Time Frame: 16 week ]
  4. Change of blood NT-proBNP after patients receiving 24 week treatment [ Time Frame: 24 week ]
  5. Cardiovascular death or heart failure re-hospitalization after patients receiving 24 week treatment [ Time Frame: 24 week ]
  6. Comprehensive cause mortality after patients receiving 52 week treatment [ Time Frame: 24 week ]
  7. EQ-5D Questionnaire score after patients receiving 24 week treatment [ Time Frame: 24 week ]
  8. Change of NYHA grading after patients receiving 24 weeks treatment [ Time Frame: 24 week ]

Other Outcome Measures:
  1. Index change in hemoglobin, serum iron, ferritin and transferrin saturation, and the like patients receiving 24 week treatment [ Time Frame: 24 week ]
  2. Index change in left ventricular ejection fraction, left atrial diameter, left ventricular diameter, pulmonary artery pressure and diastolic function after patients receiving 24 week treatment [ Time Frame: 24 week ]
  3. Rehospitalization with heart failure after patients receiving 24 week treatment [ Time Frame: 24 week ]
  4. Heart failure mortality after patients receiving 24 week treatment [ Time Frame: 24 week ]
  5. Cardiovascular readmission rates after patients receiving 24 week treatment [ Time Frame: 24 week ]
  6. Cardiovascular mortality after patients receiving 24 week treatment [ Time Frame: 24 week ]
  7. Comprehensive due readmission rates after patients receiving 24 week treatment [ Time Frame: 24 week ]
  8. Comprehensive cause mortality after patients receiving 24 week treatment [ Time Frame: 24 week ]
  9. C Reactive protein level after patients receiving 24 week treatment [ Time Frame: 24 week ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign informed consent form;
  2. Between 18 to 80 years old, male or female;
  3. 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;
  4. LVEF< 40% (determined by Simpson method) (valid for one week before randomization);
  5. NYHA heart function II-III Grade;
  6. NT-proBNP>400pg/ml, it should be .900pg/ml at atrial fibrillation;
  7. 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%);
  8. Capable of 6 Minute walk test.

Exclusion Criteria:

  1. Patients with significant bleeding: gastrointestinal bleeding, menorrhagia, history of gastrointestinal bleeding and no evidence of gastrointestinal disease healing;
  2. History of oral iron supplementation and intolerance;
  3. History of acquired iron overload;
  4. 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;
  5. Patients in urgent need of blood transfusion;
  6. VtaminB12 and/or folate deficiency, unless correctable; and Non-iron deficiency anemia;
  7. 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;
  8. 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);
  9. Intestinal diseases which affect iron absorption such as inflammatory bowel disease and chronic pancreatitis;
  10. Active infection;
  11. History of syncope within 3 months, diagnosed as cardiogenic shock over the past 1 months;
  12. Active myocarditis, constrictive pericarditis and other pericardial diseases;
  13. Acute decompensated heart failure with unstable hemodynamics;
  14. Symptomatic bradycardia or second or third-degree cardiac conduction block with no pacemaker installed;
  15. 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;
  16. Valvular heart disease and congenital heart disease without operation; hypertrophic cardiomyopathy, restricted cardiomyopathy, and other secondary cardiomyopathy;
  17. Patients with malignancy;
  18. Patients combined with other organ diseases such as hematopoietic system, nervous system, endocrine system like thyroid, and combined with psychosis;
  19. There is uncontrolled hypertension, systolic pressure is greater than 180mmHg and/or diastolic pressure is greater than 110mmHg;
  20. Heart rate ≥ 130 times/minute before randomization, or malignant ventricular arrhythmia affecting hemodynamic;
  21. Neuromuscular disease, disability or other non-cardiac causes influencing the performance of 6 Minute walk test;
  22. 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;
  23. 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;
  24. Has been received major surgery within 6 months prior to randomization, or intend to receive major surgical treatment within 6 months;
  25. 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;
  26. Nursing or pregnant women, or women of childbearing age without contraception, or patients planned pregnancy in 6 months;
  27. History of major organ transplant (such as lung, liver, bone marrow, kidney)
  28. Patients have been involved or to be involved in other clinical trials within one month;
  29. Patients cannot understand the informed consent form or cannot make decisions or of poor compliance;
  30. Patients judged as unsuitable for the study and life expectancy less than 1 year by investigators.

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03344523     History of Changes
Other Study ID Numbers: 2016-ZX02
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Iron
Iron protein succinylate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics