E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with severe /refractory Congestive Heart Failure and diminished (but not terminal) renal function. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To invesigate whether Peritoneal Dialysis by 2 exchanges (a night dwell and a daytime dwell) with Extraneal improve symptoms in CHF (NYHA) at 8 months in refractory CHF as compared to standard care |
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E.2.2 | Secondary objectives of the trial |
- To invesigate whether Peritoneal Dialysis by a 1 night exchange with Extraneal improves CHF symptoms (NYHA) at 8 months in refractory CHF as compared to standard care. - To invesigate whether Peritoneal Dialysis by 2 exchanges (a night dwell and a daytime dwell) with Extraneal improves CHF symptoms (NYHA) at 8 months in refractory CHF as compared a 1 night exchange with EN. - Similarly as above objectives with other outcome parameters (number of unfavorable days, questionnaires (SF36 en Minnesota Living with Heart Failure, 6-Minute Walk Test, rehospitalizations, medication, survival).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age > 18 years. 2. Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%. 3. Diminished renal function: eGFR < 45 ml/min. 4. Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites) 5. Hospitalization for CHF during the last 6 months. 6. Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks 7. Suitable for PD.
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E.4 | Principal exclusion criteria |
1. Hypotension (SBP < 100 mmHg / MAP < 70) mmHg 2. Instable AP or recent (< 6 months) myocardial infarction. 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
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E.5 End points |
E.5.1 | Primary end point(s) |
1a. Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. As main outcome parameter the measurements at 8 months after start of PD will be used: the first 2 months patient is occupied with integrating PD in his/her life The next 3 months PD, diet and pharmaceutical therapies are optimized and the final 3 months PD is expected to result in improvement of symptoms. Initial prognosis is too pore to statistically justify significant outcomes at a later stage. Measurements of course will continue and will be analyze as long as PD continues at 4 months intervals. 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Cardiorenal Physiological responses |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the study is defined as death of the last subject in the study. This is done to enhance the possibility of the study to examine effects on survival. The study is not powered for this end-point, however it is an important endpoint, in particular because of the poor prognosis of these subjects. Therefore, the difference with the endpoint "last visit of the last subject" is expected to be small.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |