End Stage Renal DiseaseNCT02862197
Invasive Monitoring of Pulmonary Artery Pressure (PAP) Among Dialysis Treated Patients
An observational study of End Stage Renal Disease and Cardiac Insufficiency, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Cardiac Insufficiency
- How many people
- 8 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Päijät-Häme Central Hospital
Lahti, Paijat-Hame Region, 15900
Tuomas Kerola, MD, +358381911, tuomas.kerola@phsotey.fi
Seppo Ojanen, MD, +358447195895, seppo.ojanen@phsotey.fi
About this study
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.
Read the detailed description
Dialysis treatment is hemodynamically problematic in up to one third of the patients. Particularly, estimation of the adequate fluid removal during the dialysis can be difficult. Removing too much fluid can lead to dehydration, hypotension and dizziness, and insufficient removals can lead to fluid accumulation and worsening of possible heart failure. Both under- and overestimation of the fluid removal have been connected to increased mortality. Balancing the fluid balance is especially challenging in patients with simultaneous heart failure.
Several measures are made and precautions taken during the dialysis to optimize the ultrafiltration individually for each patient. The key question in the estimation of the right amount of ultrafiltration is, how much and at what speed fluid can be safely removed from the patient without critically lowering the filling and preload of the heart.
The results of the CHAMPION trial show that therapy guided by PAP is superior to conventional way in estimating the optimal fluid balance among heart failure patients. Compared to the heart failure patients in the CHAMPION trial, the ESRD patients share some similarities. In both groups, estimating the fluid balance is crucial, but difficult. The changes in fluid balance among ESRD patients are much larger.
In the present study the investigators aim to evaluate the potential of invasive measured PAP in the context of dialysis treatment for patients with end-stage renal disease (ESRD).
After the implantation the basic medical history is taken, echocardiography is made, and their laboratory measurements are recorded. Participants are then monitored during their routine dialysis treatment twice a week over the period of 1 month. In addition twice a day measurement is recorded in home during the study.
PAP measures and its changes are then compared to all the haemodynamical data available including blood volume, systolic and diastolic blood pressure, heart rate, hematocrit measures and bioimpedance measurement during the dialysis treatment.
- Conditions
- End Stage Renal Disease, Cardiac Insufficiency
- Medical subject headings
- Kidney Failure, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | hemodialysis treated patients as described in the inclusion of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pulmonary artery pressure (PAP) during the dialysis treatment
Measured: 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
Measured: measurement is made twice a day over the period of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjo Soini, Joint Authority for Päijät-Häme Social and Health Care
- Investigators
- Tuomas V Kerola, MD PhD, Principal investigator, Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862197
- Sponsor's protocol ID
- Q298diarnro18/2016
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Monitoring of Pulmonary Artery Pressure (PAP) Among Dialysis Treated Patients
- ClinicalTrials.gov ID
- NCT02862197
- Acronym / sponsor ID
- Q298diarnro18/2016
- Conditions
- End Stage Renal Disease, Cardiac Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dialysis treatment is hemodynamically problematic in up to one third of the patients. Particularly, estimation of the adequate fluid removal during the dialysis can be difficult. Removing too much fluid can lead to dehydration, hypotension and dizziness, and insufficient removals can lead to fluid accumulation and worsening of possible heart failure. Both under- and overestimation of the fluid removal have been connected to increased mortality. Balancing the fluid balance is especially challenging in patients with simultaneous heart failure.
Several measures are made and precautions taken during the dialysis to optimize the ultrafiltration individually for each patient. The key question in the estimation of the right amount of ultrafiltration is, how much and at what speed fluid can be safely removed from the patient without critically lowering the filling and preload of the heart.
The results of the CHAMPION trial show that therapy guided by PAP is superior to conventional way in estimating the optimal fluid balance among heart failure patients. Compared to the heart failure patients in the CHAMPION trial, the ESRD patients share some similarities. In both groups, estimating the fluid balance is crucial, but difficult. The changes in fluid balance among ESRD patients are much larger.
In the present study the investigators aim to evaluate the potential of invasive measured PAP in the context of dialysis treatment for patients with end-stage renal disease (ESRD).
After the implantation the basic medical history is taken, echocardiography is made, and their laboratory measurements are recorded. Participants are then monitored during their routine dialysis treatment twice a week over the period of 1 month. In addition twice a day measurement is recorded in home during the study.
PAP measures and its changes are then compared to all the haemodynamical data available including blood volume, systolic and diastolic blood pressure, heart rate, hematocrit measures and bioimpedance measurement during the dialysis treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –hemodialysis treated patients as described in the inclusion of the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of pulmonary artery pressure (PAP) during the dialysis treatment
Time frame: PAP is recorded every ten minutes during the standard dialysis treatment (4-6h). Measurement is repeated twice a week for one month
1 secondary outcome
Change of pulmonary artery pressure (PAP) in between the dialysis treatment
Time frame: measurement is made twice a day over the period of one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuomas V Kerola, MD PhD principal investigator
Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Cardiac Insufficiency, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuomas V Kerola, MD PhD (+358381911, tuomas.kerola@phsotey.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pulmonary artery pressure (PAP) during the dialysis treatment (time frame: PAP is recorded every ten minutes during the standard dialysis treatment (4-6h). Measurement is repeated twice a week for one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017; AzTrials last refreshed its copy on 9 Nov 2026.