The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients (Bio-SHiFT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01851538|
Recruitment Status : Active, not recruiting
First Posted : May 10, 2013
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment|
|Heart Failure||Other: Observational study; no intervention.|
|Study Type :||Observational|
|Actual Enrollment :||399 participants|
|Official Title:||Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
|Chronic heart failure patients visiting the outpatient clinic||
Other: Observational study; no intervention.
- The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure. [ Time Frame: maximum follow-up is 2.5 years ]
- Cardiovascular death [ Time Frame: maximum follow-up is 2.5 years ]
- Cardiac transplantation [ Time Frame: maximum follow-up is 2.5 years ]
- Left ventricular assist device implantation [ Time Frame: maximum follow-up is 2.5 years ]
- Re-hospitalization for acute or worsened heart failure [ Time Frame: maximum follow-up is 2.5 years ]
- Cardiovascular disease: myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) [ Time Frame: maximum follow-up is 2.5 years ]Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components.
- All-cause mortality [ Time Frame: maximum follow-up is 2.5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851538
|Medical Center Alkmaar|
|Study Chair:||Eric Boersma, MSc, PhD||Erasmus MC|
|Study Director:||Isabella Kardys, MD, PhD||Erasmus MC|
|Principal Investigator:||Victor Umans, MD, PhD||Medical Center Alkmaar|
|Principal Investigator:||Martijn Akkerhuis, MD, PhD||Erasmus MC|