SYMPTOMATIC IMPROVEMENT BY PERITONEAL DIALYSIS IN PATIENTS WITH END STAGE CONGESTIVE HEART FAILURE - PD in CHF

• Conditions: Subjects with severe /refractory Congestive Heart Failure and diminished (but not terminal) renal function.

• Registration Number: EUCTR2009-017711-15-NL
• Lead Sponsor: Martini Ziekenhuis Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified