Heart Failure Clinical Trial
— PD-HFOfficial title:
PD-HF: A Multi-centre Randomised Controlled Trial of Intermittent Peritoneal Dialysis With Icodextrin-based Solutions on Patients With Severe Heart Failure and Stage 3-4 Chronic Kidney Disease
Verified date | January 2020 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.
Status | Terminated |
Enrollment | 11 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Severe heart failure (NYHA grade III or IV) - Chronic kidney disease stage 3-4 - Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months - Left ventricular ejection fraction =40% in last 2 years (moderate/severe) - Using optimal HF medication for = 4 weeks including ACE-inhibitor (angiotensin-converting-enzyme inhibitor) OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for = 4 weeks - Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated. Exclusion Criteria: - Does not wish to participate - Mental incapacity to consent - CKD stage 5 - Normal renal excretory function - Haemodynamically significant valvular disease amenable to surgery - Cardiac or renal transplantation - Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Derby Teaching Hospitals NHS Foundation Trust | Derby | Derbyshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | British Heart Foundation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Episodes of PD associated peritoneal infection | Recording the numbers of PD associated peritoneal infections | Baseline to week 28 | |
Other | Adverse events spontaneously reported during the study | Recording and reporting adverse events | Baseline to week 28 | |
Other | Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires | Comparison between the scores from pen and ink questionnaires and the online visual analogue scale | Baseline to week 28 | |
Primary | The primary end-point is a change of 25 metres walked | 6 Minute Walk Test | Baseline to week 28 | |
Secondary | Change in KCCQ score | Kansas City Cardiomyopathy Questionnaire | Baseline to week 28 | |
Secondary | Change in SF36 score | Short Form 36 questionnaire | Baseline to week 28 | |
Secondary | Change in Derby Evaluation of Illness online visual analogue scale | Derby Evaluation of Illness online visual analogue scale | Baseline to week 28 | |
Secondary | Heart Failure related hospitalisations | Recording the number of hospitalisations relating to Heart Failure | Baseline to week 28 | |
Secondary | All cause hospitalisations | Recording the number of hospitalisations for all causes | Baseline to week 28 | |
Secondary | Heart failure related mortality | Recording the number of heart failure deaths | Baseline to week 28 | |
Secondary | All cause mortality | Recording the number of all cause deaths | Baseline to week 28 |
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