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Clinical Trials/NL-OMON38127
NL-OMON38127
Completed
Phase 3

SYMPTOMATIC IMPROVEMENT BY PERITONEAL DIALYSIS IN PATIENTS WITH END STAGE CONGESTIVE HEART FAILURE - Peritoneal dialysis in congestive heart failure.

Martini Ziekenhuis0 sites45 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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