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

NCT03344523 | Unknown Phase 4

• 1 other identifier: 2016-ZX02
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Heart Failure; Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• The change of 6 Minute walk distances

  The change of 6 Minute walk distances compared to baseline after patients receiving 24 week treatment.

  24 week

Secondary Outcomes (8)

• Variety of overall status score（PGA）after patients receiving 24 week treatment

  24 week

• Kansas City Cardiomyopathy Questionnaire (KCCQ) rating change after patients receiving 24 week treatment

  24 week

• Change of 6 Minute walk distance after patients receiving 16 week treatment

  16 week

• Change of blood NT-proBNP after patients receiving 24 week treatment

  24 week

• Cardiovascular death or heart failure re-hospitalization after patients receiving 24 week treatment

  24 week

Other Outcomes (9)

• Index change in hemoglobin, serum iron, ferritin and transferrin saturation, and the like patients receiving 24 week treatment

  24 week

• 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

  24 week

• Rehospitalization with heart failure after patients receiving 24 week treatment

  24 week

Study Arms (2)

standard treatment + Iron succinylate

EXPERIMENTAL

1 bottle orally, twice daily, take orally before meals

Drug: Iron protein succinylate oral solution; Other: standard treatment

standard treatment + placebo

PLACEBO COMPARATOR

1 bottle orally, twice daily, take orally before meals

Other: standard treatment

Interventions

Iron protein succinylate oral solution DRUG

Iron protein succinylate oral solution

standard treatment + Iron succinylate

standard treatment OTHER

standard treatment

standard treatment + Iron succinylate; standard treatment + placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

iron protein succinylate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share