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Dynamic Changes in SDF-1α Levels in Acute and Stabilized Heart Disease (DYNASDY)

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ClinicalTrials.gov Identifier: NCT02702752
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Lawkesh Vimal Hurry, Copenhagen University Hospital, Hvidovre

Brief Summary:

The aims of the present study are to measure dynamic changes over time in the plasma level of SDF-1α in patients with confirmed diagnoses of AMI, AF and CHF and in so doing:

  1. Monitor the plasma level of SDF-1α at the diagnosis, during and after the long term treatment of AMI, AF and CHF. The SDF-1α level of patients is expected to decrease during treatment of the aforementioned conditions.
  2. Correlate the plasma level of SDF-1α in relation to clinical, biochemical characteristics of Acute Myocardial Infarction(AMI), Atrial Fibrillation(AF) and Congestive Heart Failure (CHF). In so doing, the investigators expect that SDF-1α will correlate with the severity of heart disease.
  3. Study the dynamic of SDF-1α pertaining to its property as prognostic indicator for the long term follow up risk of readmission and mortality of patients diagnosed with AMI, AF or CHF.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ischemic Heart Disease Congestive Heart Failure Other: DYNASDY Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Changes in Stromal Cell-derived Factor-1α Levels in Acute and Stabilized Heart Disease - ACUTE MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, AND HEART FAILURE (THE DYNASDY STUDY)
Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DYNASDY
The study considers changes in SDF-1α levels in response to treatment of cardiac disease (myocardial infarction, heart failure or atrial fibrillation). SDF-1α levels will be measured at the acute stages of the disease, after stabilization and at longer term as detailed below. Levels of SDF-1α will be correlated to the outcome of disease.
Other: DYNASDY
Measurement of SDF-1 alpha levels i patients' blood samples.

Active Comparator: Control group
A control group of 20 subjects without cardiac disease (including hypertension), diabetes, hypercholesterolemia, and malignant disease.
Other: DYNASDY
Measurement of SDF-1 alpha levels i patients' blood samples.




Primary Outcome Measures :
  1. Dynamic changes in SDF-1α levels for use as a prognostic factor during and after treatment of Acute Myocardial Infarction, Atrial Fibrillation and Heart Failure. [ Time Frame: 6 months ]
    This study aims to evaluate the dynamic changes in SDF-1α levels during and after treatment of three major heart diseases. Results will aid in the understanding of the role of SDF-1α in cardiac disease. If disease progression and treatment effect is reflected in the levels of SDF-1α, measurement of this biomarker will be a valuable tool for monitoring disease course and treatment effect and, in so doing, help in risk evaluation and individualized treatment of patients suffering from cardiac disease.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients are included from the in-patient department of the Department of Cardiology, Hvidovre University Hospital. Patients are eligible for inclusion if diagnosed with one of the following diseases:

  • myocardial infarction
  • atrial fibrillation
  • heart failure

Exclusion Criteria: Patients must not suffer from one of the follwing conditions:

  • malignant disease
  • diabetes mellitus types I or II
  • have a life expectancy of at least one year.

Information from the National Library of Medicine

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): NCT02702752


Locations
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Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Of Denmark, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Study Chair: Nadia Landex, Ph.D. Department of Cardiology, Roskilde University Hospital
Study Chair: Ema Ema Rastoder, MB Department of Cardiology, Copenhagen University Hospital Hvidovre
Study Chair: Maha Maha Alsawaf, MB Department of Cardiology, Copenhagen University Hospital Hvidovre
Study Director: Anne Langkilde, MS, Ph.D. Clinical Research Centre, Copenhagen University Hospital Hvidovre
Study Director: Ove Andersen, M.D., Ph.D. Clinical Research Centre, Copenhagen University Hospital Hvidovre

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Responsible Party: Lawkesh Vimal Hurry, M.D., Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT02702752     History of Changes
Other Study ID Numbers: H-15007626
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It a randomized study where all data will be anonymous.
Keywords provided by Lawkesh Vimal Hurry, Copenhagen University Hospital, Hvidovre:
Heart diseases stromal differentiation factor alpha 1
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases