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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01124227
Other study ID # PDinCHF
Secondary ID 2009-017711-15
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 2010
Est. completion date September 2017

Study information

Verified date August 2019
Source Martini Hospital Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.

Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..

Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years).

Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).

Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. 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).


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date September 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%

- Diminished renal function: eGFR < 60 ml/min

- Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)

- Hospitalization for CHF during the last 6 months

- Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks

- Suitable for PD

Exclusion Criteria:

- Hypotension (SBP < 100 mmHg / MAP < 70) mmHg

- Instable AP or recent (< 6 months) myocardial infarction.

- Contraindications for PD (e.g. visual handicap, social)

- Liver failure

- COPD Gold class IV

- Malignancy with life expectancy < 2 years

- Non compliance

- No informed consent

- Poor mental health

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.

Locations

Country Name City State
Netherlands Martini Hospital Groningen

Sponsors (3)

Lead Sponsor Collaborator
Martini Hospital Groningen Baxter Healthcare Corporation, Roche BV Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients in NYHA class I, II, III, or IV as measure of quality of life 8 months
Secondary Quality of life measures Reduction in unfavorable days. Short-Form 36. Minnesota Living with Heart failure Questionnaire. 6 minute walk test. (re)hospitalization. Survival. Medication optimalisation. Cardial: LVH. Renal: GFR/ERPF/FF; KIM-1, NGAL, NAG. Volume status: ECV (radioactive and bio-impedance). Neurohumoral and inflammatory parameters. 8 months
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