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Peritoneal dialysis using icodextrin-based solutions for patients with advanced heart failure and chronic kidney disease

PD-HF: a multicentre randomised controlled trial of Peritoneal Dialysis using icodextrin-based solutions for patients with advanced Heart Failure and stage 3-4 chronic kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22848383
Enrollment
130
Registered
2015-01-09
Start date
2015-03-30
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

Participants will be randomised into receiving best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group).

Sponsors

University of Nottingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged>18, no upper age limit 2. Severe HF (New York Heart Association grade III or IV) 3. Chronic Kidney Disease stage 34, (MDRD estimated GFR of 1660ml/min on 2 occasions >3 months apart) 4. Fluid overload resistant to diuretics* OR hospital admission for heart failure in last 6 months 5. Left ventricular ejection fraction = 40% in the last 2 years 6. Using optimal HF medication for = 8 weeks including ACE-inhibitor OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for = 4 Weeks. 7. Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated. *Diuretic resistance is defined as clinical signs of fluid overload despite >120mg of furosemide/3mg bumetanide/day. ‘Fluid overload’ is clinically defined as at least 2 of the following: 1. Peripheral or sacral oedema 2. Jugular venous distension = 7cm 3. Radiographic pulmonary oedema or pleural effusion 4. Enlarged liver or ascites 5. Pulmonary rales, paroxysmal nocturnal dyspnoea, or orthopnoea

Exclusion criteria

Exclusion criteria: 1. Does not wish to participate 2. Mental incapacity to consent 3. CKD stage 5 (estimated GFR of 60ml.min) 5. Haemodynamically significant valvular disease amenable to surgery 6. Cardiac or renal transplantation 7. Considered by the investigator to be unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason

Design outcomes

Primary

MeasureTime frame
1. Assess the efficacy of ultrafiltration by PD 2. To assess the efficacy of ultrafiltration by PD in patients with severe HF and moderate CKD on symptoms of HF

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026