End Stage Renal Disease Clinical Trial
Official title:
Invasive Monitoring of Pulmonary Artery Pressure (PAP) Among Dialysis Treated Patients
The purpose of this study is examine whether invasive pulmonary artery pressure (PAP) monitoring could be beneficial for the patients in dialysis treatment. Ten implantable pressure sensors (CardioMEMS ®) will be implanted and the PAPs of the individual participants are recorded during and in between the routine dialysis treatment sessions. This is an exploratory pilot study, where major interest lies in the values and changes in PAP in relation to other hemodynamic parameters among patients in dialysis treatment. Implanted device is only monitoring the patient without any effect on the actual treatment.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | October 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria (In addition to details described in "Study Population Description"): - Subject who is eligible for a CardioMEMS device per physician discretion - Subject is living at home - Subject's ability to take part of the study will be discussed with their treating nephrologist. - Subject is willing and capable of providing informed consent, participating in all associated study activities Exclusion Criteria: - Any non-cardiac or non-renal medical condition causing the life-expectancy to be less than one year. - The patient is not able to take part of the study or the study can be considered to be harmful for the patient in the opinion of the investigator or the treating nephrologist. - Age >75 years - Age <18 years - Probable noncompliance - Subjects with an active infection - Subjects who, in the investigator's opinion, are unable to tolerate a right heart catheterization - Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of the baseline visit - Subjects with a device (Pacemaker/Implantable Cardioverter-Defibrillator/CRT) implanted < 30 days prior to enrollment - Subjects with congenital heart disease or mechanical right heart valve(s) - Subjects likely to undergo heart transplantation or ventricular assist device implantation within 6 months of the baseline visit - Subjects with known coagulation disorders or subjects who are unable to take two types of blood thinning medications or anticoagulation therapy for one month after the sensor is implanted. - Subject is enrolled in another study with an active treatment arm - Pregnancy - Diameter of Pulmonary Artery <7-10 mm - Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis |
Country | Name | City | State |
---|---|---|---|
Finland | Päijät-Häme Central Hospital | Lahti | Päijät-Häme |
Lead Sponsor | Collaborator |
---|---|
Joint Authority for Päijät-Häme Social and Health Care |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of pulmonary artery pressure (PAP) during the dialysis treatment | PAP is recorded every ten minutes during the standard dialysis treatment (4-6h). Measurement is repeated twice a week for one month | ||
Secondary | Change of pulmonary artery pressure (PAP) in between the dialysis treatment | measurement is made twice a day over the period of one month |
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