Invasive Monitoring of Pulmonary Artery Pressure (PAP) Among Dialysis Treated Patients

NCT02862197 | Unknown

• 1 other identifier: Q298diarnro18/2016
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; Cardiac Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of pulmonary artery pressure (PAP) in between the dialysis treatment

  measurement is made twice a day over the period of one month

Study Arms (1)

study group

hemodialysis treated patients as described in the inclusion of the study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten patients receiving hemodialysis treatment will be recruited for the implantation of the CardioMEMS HF System. Five of them will be patients with ESRD caused by polycystic kidney disease or glomerulonephritis with no evidence of cardiovascular disease. The other five will be patients with ESRD and hemodynamical instability during and in between dialysis treatments, defined as ultrafiltration rate minimum of 800 ml/hour and dialysis hypotension.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, Paijat-Hame Region, 15900, Finland

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Tuomas V Kerola, MD PhD

  Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuomas V Kerola, MD PhD

CONTACT

+358381911; tuomas.kerola@phsotey.fi

Seppo Ojanen, MD PhD

CONTACT

+358381911; seppo.ojanen@phsotey.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study coordinator

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: August 10, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)