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

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Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT00853541
Run by: Massachusetts General Hospital
People needed: 0
Starts: 2009-03-01
Expected to finish: 2011-10-01
Last updated by the study team: 2015-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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