Recruiting

Observational Study

Sponsor:

Coney Island Hospital, Brooklyn, NY

Code:

NCT03628443

Conditions

Cardio-Renal Syndrome

Heart Failure

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fibroblast Growth Factor 23

Study Details

Brief summary:

This is prospective cohort study with the purpose of improving our understanding of morbidity and mortality risk in patients with heart failure and chronic kidney disease.

Conditions

Cardio-Renal Syndrome

Heart Failure

Chronic Kidney Diseases

Study ID

NCT03628443

Start date

Jul 19, 2018

Status verified date

Oct, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Oct 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have a diagnosis of congestive heart failure

Exclusion Criteria:

  • Patients cannot be on hemodialysis at the study onset.
  • Patients cannot have hyperphosphatemia defined as persistent serum phosphorus level>4.5mg/dL at study onset.
  • Patients cannot be part of another study for the investigational treatment of heart failure or chronic kidney disease.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Heart Failure without Chronic Kidney Disease

This group has patients managed with all types of heart failure without concomitant chronic kidney disease.

Heart Failure with Chronic Kidney Disease

This group has patients managed with all types of heart failure with concomitant chronic kidney disease, without evidence of sustained hyperphosphatemia.

Interventions

Fibroblast Growth Factor 23

A sample of blood is tested for levels of fibroblast growth factor 23

Primary outcome measure

  • Mortality [ Time Frame: 1 year from sample date ]
  • Worsening Renal Function [ Time Frame: 1 year from sample date ]
  • Worsening Cardiac Function [ Time Frame: 1 year from sample date ]
  • End-Stage Renal Disease Progression [ Time Frame: 1 year from sample date ]

Central Contacts and Locations

Central contacts

Wesley A Romney, MD

718-616-3779romneyw@nychhc.org

Karen A Hultberg

718-616-5627karen.hultberg@nychhc.org

Locations

Coney Island Hospital

Recruiting

Brooklyn, New York, United States, 11235

Contacts

Wesley A Romney, MD

718-616-3779romneyw@nychhc.org

Karen A Hultberg

718-616-5627karen.hultberg@nychhc.org

Principal Investigator:

George Juang, MD

More Information

Sponsor

Coney Island Hospital, Brooklyn, NY

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Keywords

  • CKD
  • HFrEF
  • HFpEF
  • FGF23
  • Dialysis
  • Atherosclerosis
  • Coronary Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Coney Island Hospital, Brooklyn, NY on 2018-10-16.