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The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients

NCT01851538 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 398

Last updated 2021-02-08

No results posted yet for this study

Summary

The Bio-SHiFT study aims to investigate whether disease progression in individual patients with chronic heart failure (CHF) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. Secondary objectives of the study include comparison of 2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic measurements to clinical outcome.

Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.

Conditions

Interventions

OTHER

Observational study; no intervention.

Sponsors & Collaborators

Principal Investigators

  • Eric Boersma, MSc, PhD · Erasmus Medical Center

  • Isabella Kardys, MD, PhD · Erasmus Medical Center

  • Victor Umans, MD, PhD · Medical Center Alkmaar

  • Martijn Akkerhuis, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851538 on ClinicalTrials.gov