Iron Repletion Improves Functional Health for Heart Failure Patients
- Stable Class II-IV CHF on max tolerated therapy
- EF </= 35%; able to walk for 6MWT
- HGB> 9.0 and < 13.5 ♀ OR < 15.0 ♂
- Hospitalized for CHF in last 12mo OR NT-pro BNP >600 (NSR) or >1000 (AF)
- Significant liver or kidney impairment
- MI, ACS, TIA or CVA in last 3 months
- Receipt of EPO type drugs in last 3 months
- IV iron or blood transfusion in last 3 months
- Cancer in last 3 years; AF at rate of >100
- GI bleeding, severe uncorrected valve disease
- Current or planned oral iron supplementation
For study information search NCT03037931
Five years. That’s the estimated life span for 50 percent of the 5.7 million adults in the United States diagnosed with heart failure. But a new clinic trial is expected to test whether an iron infusion will improve those years and add even more for those with this debilitating disease.
The Duke Clinical Research Institute HEART-FID study began March 15, 2017, at 116 hospitals across the country, including the CHI Health Research Center at Creighton University Medical Center - Bergan Mercy and CHI Health Nebraska Heart Institute. Cardiologist Venkata Alla, MBBS, and his team at CUMC-BM are currently screening patients to enroll in this study. To date, 3,014 people are participating in this five-year, double-blind, placebo-controlled study with the hope of gaining FDA approval of intravenous ferric carboxymaltose as a treatment for heart failure patients.
“That something as simple as IV iron repletion could improve functional health, morbidity defined as cardiovascular hospitalization and mortality for those with systolic heart failure could be life changing for my patients,” Alla said. “And it’s only two doses on day 0 and 7 with additional dosing every six months if needed.”
Alla, principal investigator at the Omaha site, explains that iron deficiency, absolute or relative, is a frequent comorbidity present in almost 50 percent of patients with systolic heart failure and is associated with poor prognosis and functional outcomes irrespective of the presence of concomitant anemia. Prior research has demonstrated that iron replacement can improve NYHA functional class, six-minute walk distance and quality of life. While both oral and intravenous supplements can potentially improve outcomes, oral iron supplements can have suboptimal results due to impaired absorption secondary to intestinal mucosal edema in heart failure patients.
Both teams are actively recruiting patients and remind health care providers that patients can have normal hemoglobin levels and still be iron deficient. To refer a patient to this study, call (402) 343-8511.