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

This study has been withdrawn prior to enrollment.
(No patients enrolled.)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00853541
First received: February 26, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • major cardiovascular event (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples are taken


Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
heart failure with renal impairment
Heart Failure patients with renal impairment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

150 heart failure patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853541

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genzyme, a Sanofi Company
Investigators
Principal Investigator: James L Januzzi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: James L Januzzi jr, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853541     History of Changes
Other Study ID Numbers: 2008P001164
Study First Received: February 26, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
renal impairment
heart failure
hyperphosphatemia
coronary artery calcification

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

ClinicalTrials.gov processed this record on April 17, 2014