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Calcium, Phosphate, Renal Impairment and Coronary Artery Disease in the Cardio-renal Syndrome, The CAPRICORN-CRS Study (CAPRICORN)

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: NCT00853541
Recruitment Status : Withdrawn (No patients enrolled.)
First Posted : March 2, 2009
Last Update Posted : September 24, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Heart failure (HF) is a major public health problem, which affects about 5 million Americans.HF is when the heart muscle does not pump as much blood as the body needs. As a result of this,the body has difficulties in keeping an optimal fluid status. The fluid status of the body is regulated by both the heart and the kidneys. Due to the strong interaction between the heart and the kidneys, heart failure can result in a slight decreased kidney function as well.

It is known that people who primarily suffer from chronic kidney disease (CKD) have a higher risk of developing arterial calcifications. Calcification of the arteries is caused by deposits of calcium within the walls of the blood vessels. Calcifications of the arteries may result in a loss of elasticity of the blood vessels. Recent research studies have shown that people with CKD have stiffer blood vessels which in these people, is associated with a higher chance of developing cardiovascular diseases.

However, it is not known whether a decrease in kidney function in people with HF results in arterial calcification as well. In addition, it is not known whether this is also associated with a higher risk of developing cardiovascular diseases (diseases of the heart and blood vessels.) We are asking you to take part in this study because you have HF combined with some decrease in your kidney function.

The purpose of this study is to see whether people with HF and a decrease in kidney function do have a higher chance of developing arterial calcifications. We will do this by comparing the results of the following; 1) several blood tests, 2) pictures taken of your heart by echocardiogram and computed tomography (CT) scan, and 3) measurements of the elasticity of your arteries. All of these tests are routinely used in clinical care. However, there have not been any research studies that have compared these results to see how they relate to arterial calcification in people with HF who have a decrease in kidney function.

We also want to see whether people with HF and a decreased kidney function are at a higher risk of developing cardiovascular diseases. This study is being performed at Massachusetts General Hospital (MGH), in Boston Massachusetts. We expect to enroll a total of 150 subjects at MGH.

Condition or disease
Heart Failure

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Calcium, Phosphate, Renal Impairment and Coronary Artery Disease in the Cardio-renal Syndrome, The CAPRICORN-CRS Study
Study Start Date : March 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

heart failure with renal impairment
Heart Failure patients with renal impairment

Outcome Measures

Primary Outcome Measures :
  1. overall mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. major cardiovascular event (MACE) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
blood samples are taken

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 heart failure patients

Inclusion Criteria:

  • Men and women of 18 years old or older
  • history and clinical findings of heart failure for at least three months before screening
  • Patients have to be in New York Heart Association (NYHA) class II, III, or IV and clinically stable
  • Left ventricular ejection fraction <50%
  • GFR ≤ 40 ml/min/1.73m² as calculated the abbreviated MDRD formula

Exclusion Criteria:

  • pregnancy as determined by urine test for reproductive-aged females
  • current or past renal replacement therapy
  • current treatment for hyperphosphatemia
  • a history of renal transplantation or CABG
  • Symptoms consistent with Canadian Cardiovascular Society > class 1 angina
  • Inability to comprehend or unwillingness to sign informed consent
  • chronic atrial fibrillation
Contacts and Locations

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): NCT00853541

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: James L Januzzi, MD Massachusetts General Hospital
More Information

Responsible Party: James L. Januzzi, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853541     History of Changes
Other Study ID Numbers: 2008P001164
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by James L. Januzzi, Massachusetts General Hospital:
renal impairment
heart failure
coronary artery calcification

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Cardio-Renal Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases