Peritoneal Dialysis in Congestive Heart Failure

Congestive Heart Failure Clinical Trial

— PDinCHF  

Official title:

Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01124227
• Other study ID #: PDinCHF
• Secondary ID: 2009-017711-15
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

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