To improve symptomatology in severe chronic failure patients.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1a. Reduction in NYHA classification of symptomatic Congestive Heart Failure at
8 months after start of PD therapy with 2 dwells of Extraneal during 24 hours.
1b. Burden of congestive heart failure: measured by reduction in unfavorable
days (noted by patients in diaries and including days of hospitalization for
CHF-deterioration and death) with 2 dwells of Extraneal during 24 hours.
Secondary outcome
2. QoL measured as general status by the Short-Form 36.
3. QoL measured as health-specific status by the Minnesota Living with Heart
Failure Questionnaire.
4. VO2max measured by a standardized physical exertion 6-minute walk test.
5. Number and length of (re)hospitalizations for CHF, as well as total number
of hospitalizations.
6. (increase) in optimal medication: dose of ACEI, ARB, spironolactone (total
dose/day).
7. Survival: subjects alive at 8 months and thereafter, Kaplan Meier, length
of life, causes of death.
8. Cardiovascular: - improvement in 6 minute walk test;
- reduction in LVH / LVM
9. Renal/PD: - Urinary protein, urinary biomarkers: (KIM-1, NGAL, NAG);
- Residual kidney function (urea +
creatinine clearance), KT/V
- GFR / ERPF / FF with
iothalamate/hippuran
10. Volume status: - extracellular volume with iothalamate
- bio-impedance
11. Neurohumoral: - changes in: PRA, Aldosterone, NT-proBNP, ADH, osmolality
- reduction in peripheral vascular
resistance
12. Inflammatory: - hsCRP, cytokines
13. Nutritional: - albumin
- lipid spectrum
14. Cost/ effectiveness of PD
Background summary
Chronic heart failure is a serious invalidating condition which incidence
increases substantially. Psychosocial burden and medical costs are high.
Medical therapy has improved but the limits are obvious. Peritoneal dialysis is
promising to make remarkable improvements in the invalidating symptoms and in
improving quality of life. It is possible that medical therapy on top of
peritoneal dialysis can be intensified and therewith contributes to a furhter
quality of life improvement.
Randomized studies are lacking, there are no systematic observations and we do
not know to what extent peritoneal dialysis should be offered to patients with
chronic heart failure.
Study objective
To improve symptomatology in severe chronic failure patients.
Study design
Multicentre Open, parallel.
Comparing 2 schemes of peritoneal dialysis with Extraneal with standard medical
therapy
Intervention
Peritoneal dialysis with Extraneal.
Study burden and risks
The burden of the illness-related symptoms in view of the poor prognosis is
high. Several events may occur due to the undelying condition.
The largest risk related to this study is the operative risk related to the
endoscopic-operative placement of the PD-catheter. However, this is a standard
procedure in another group of patients, namely those with renal failure who
have a comparable or maybe even higher risk profile: they do not only suffer
from renal failure, but almost always also from some kind of (sometimes
serious) heart failure. The risks that have been observed in that group do
exist, but fortunately are not frequent in daily practice. Another risk related
to the PD-catheter is the development of peritonitis. In renal insufficient
patients this complication almost always can be treated with antibiotics
without further complications. Finally, sometimes there is catheter
malfunction.
Subjects are also asked to attend the outpatient clinic several times for
additional investigations. In all groups these are 5 study days: at baseline,
1, 2, 5, and 8 months. On these days a physical examination and laboratory
measurements (serum and 24-hour urine collection) are performed, as well as
measurements of extracellular volume with bio-impedance as peripheral vascular
resistance with a blood pressure measurement device. Questionnaires are filled
in at 0, 2, 5, and 8 months; exact measurements of extracellular volume and
renal function are done at 0 and 2 months; a 6-min walk test and echo
cardiography are performed at 0 and 8 months. Furthermore subjects are asked to
qualify the favorability of their condition daily. In the intervention groups
there are 7 extra outpatient visits for control; these visits are simple (15
min) and follow the normal procedure and frequency as PD treatment in patients
with renal insufficiency.
It can be expected that the burden is acceptable in view of the (clinically
significant) improvement in symptoms and decrease in (number / lengths) of
hospitalizations. Moreover, patients who are not within the trial will also
have frequent outpatients visits to control for their invalidating condition.
Van Swietenplein 1
Groningen 9700 RM
NL
Van Swietenplein 1
Groningen 9700 RM
NL
Listed location countries
Age
Inclusion criteria
Patients with refractory congestive heart failure, class 3-4:
1. Age > 18 years.
2. Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%.
3. Diminished renal function: eGFR < 60 ml/min, as mean of the last three measurements.
4. Clinically volume overloaded: dyspnoea NYHA III-IV, edema, and/or ascites
5. Chronic CHF during the last 6 months despite evaluation and optimalization by a cardiologist.
6. Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks.
7. Suitable for PD.
Exclusion criteria
1. Hypotension (SBP < 100 mmHg / MAP < 70 mmHg).
2. Instable AP or an elevated troponine-I level > 0,4 ug/l within the last 3 months or > 1 ug/l within the last 6 months.
3. Contraindications for PD (e.g. visual handicap, social).
4. Liver failure.
5. COPD Gold class IV.
6. Malignancy with life expectancy < 2 years.
7. Non compliance.
8. No informed consent.
9. Poor mental health.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017711-15-NL |
| ClinicalTrials.gov | NCT01124227 |
| CCMO | NL29197.099.09 |