Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors (IMPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510792
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
There are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ED) or who are hospitalised (excluding those already receiving dialysis). Renin-angiotensin-aldosterone system inhibitors (RAASi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (HFrEF) and post myocardial infarction (MI) left ventricular systolic dysfunction (LVSD) and as such should be continued wherever possible for these indications. These drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of RAASi. Yet it remains unknown how common this happens in standard clinical practice. Inappropriate discontinuation of RAASi in such patients may lead to adverse clinical outcomes. If patients have hyperkalaemia that limits the use of RAASi, they may be candidates for new potassium binders that could facilitate their continued use.

Condition or disease Intervention/treatment
Hyperkalemia Other: No intervention

Detailed Description:

Research questions:

In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:

  1. How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
  2. What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
  3. What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: No intervention
    No intervention

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia. [ Time Frame: 12 months ]
    Proportion of hospitalised patients/ED attenders receiving RAASi for clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.

  2. Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia. [ Time Frame: 12 months ]
    Proportion of hospitalised patients/ED attenders receiving RAASi without clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.


Secondary Outcome Measures :
  1. Recurrent hyperkalaemias. [ Time Frame: 12 months ]
    Number of repeated episodes of hyperkalaemia after initial episode according to laboratory reports (episodes can be as inpatient or outpatient) captured during study period.

  2. Proportion of patients continuing of RAASi. [ Time Frame: 3 months and 12 months ]
    Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months.

  3. Hospitalisations [ Time Frame: 12 months ]
    Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months

  4. Mortality [ Time Frame: 12 months ]
    Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.

  5. Level of hyperkalaemia leading to changes to RAASi. [ Time Frame: 12 months ]
    Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)
Criteria

Inclusion Criteria:

  1. Patients in ED or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l
  2. Receiving RAASi.
  3. Aged 18 and above.
  4. Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.

Exclusion Criteria:

  1. Patients already receiving dialysis prior to the episode of hyperkalaemia.
  2. For patients considered for postal consent: known cognitive impairment, learning difficulties or brain injury or those who had transient cognitive impairment, delirium or required urgent deprivation of liberty form completion during inpatient stay or in the previous 12 months prior to hyperkalaemia episode.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510792


Contacts
Layout table for location contacts
Contact: Elena Cowan, PhD 02392 286000 ext 6750 elena.cowan@porthosp.nhs.uk
Contact: Anna Cunnington 02392 286000 ext 4523 anna.cunnington@porthosp.nhs.uk

Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Vifor Pharma
Investigators
Layout table for investigator information
Principal Investigator: Paul R Kalra, Professor Portsmouth Hospitals University NHS Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04510792    
Other Study ID Numbers: PHT/2020/60
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Portsmouth Hospitals NHS Trust:
Hyperkalemia due to RAASi
RAASi
Hyperkalaemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases