SYMPTOMATIC IMPROVEMENT BY PERITONEAL DIALYSIS IN PATIENTS WITH END STAGE CONGESTIVE HEART FAILURE

Phase 3

Completed

• Conditions: 10019280; cardiac decompensation; heart failure

• Registration Number: NL-OMON38127
• Lead Sponsor: Martini Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1a. Reduction in NYHA classification of symptomatic Congestive Heart Failure at<br /><br>8 months after start of PD therapy with 2 dwells of Extraneal during 24 hours.<br /><br><br /><br>1b. Burden of congestive heart failure: measured by reduction in unfavorable<br /><br>days (noted by patients in diaries and including days of hospitalization for<br /><br>CHF-deterioration and death) with 2 dwells of Extraneal during 24 hours.</p><br>