NL-OMON38127
Completed
Phase 3
SYMPTOMATIC IMPROVEMENT BY PERITONEAL DIALYSIS IN PATIENTS WITH END STAGE CONGESTIVE HEART FAILURE - Peritoneal dialysis in congestive heart failure.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- cardiac decompensation
- Sponsor
- Martini Ziekenhuis
- Enrollment
- 45
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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