Heart Failure With Reduced Ejection Fraction Clinical Trial
— REVIEWOfficial title:
BuRden of Hyperkalaemia and EValuatIon of changEs to Therapy With Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium
NCT number | NCT04249648 |
Other study ID # | PHT/2020/11 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 12, 2021 |
Est. completion date | April 30, 2025 |
Renin-angiotensin-aldosterone system inhibitors (RAASi) have transformed prognosis of patients with heart failure with reduced ejection fraction, diabetic nephropathy and chronic kidney disease. However, in everyday clinical practice patients often receive suboptimal doses of RAASi. The development of hyperkalaemia is one of the reasons for dose reduction or complete withdrawal of RAASi and this in turn is likely to have an adverse impact on patient outcomes. Yet it remains unknown precisely how often hyperkalaemia leads to changes to RAASi doses, if it is the sole reason, or whether this occurs in combination with other clinical situations such as worsened renal function and hypotension. It is also unclear what influences the decision-making process of healthcare professionals in managing patients with hyperkalaemia who take RAASi and if this is influenced by specialty, experience or indications for RAASi. In order to improve our understanding of the problem we are taking forward a research study (made up of 3 complimentary studies). These data are needed to help achieve our ultimate goal of improving the care of patients with prognostic indication for RAASi.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | For patients with heart failure Inclusion criteria 1. Patients with newly diagnosed HFrEF (within 4 weeks of diagnosis, including those with post MI LVSD, identified as outpatients or during hospital admission, typically for decompensated heart failure or post myocardial infarction) who are initiated on RAASi or have a clinical indication for uptitration of current RAASi (in patients already receiving RAASi for other indications). 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. Patients receiving dialysis. For patients with hyperkalaemia Inclusion criteria 1. Patients in ED or inpatients who already receive RAASi and who have at least 1 blood test with a potassium level of =5.5 mmol/l. 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. Patients receiving dialysis. For healthcare professionals: Inclusion criteria 1. Doctors, pharmacists, non-medical prescribers working at primary and secondary care. 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. None As this is an observational study, patients in other research studies or receiving any specific treatments for hyperkalaemia (other than chronic dialysis) will not be excluded. After consent, patients will also be permitted to participate in other research studies should they so wish. Patients with covid-19 can also be included. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Portsmouth Hospitals University NHS Trust | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Portsmouth Hospitals NHS Trust | Vifor Pharma |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of hyperkalaemia in patients with new diagnosis of HFrEF | Incidence of hyperkalaemia in patients with new heart failure with reduced ejection fraction started on renin-angiotensin-aldosterone receptor inhibitor(s) | 12 months | |
Primary | Frequency of dose reduction/withdrawal for RAASi after hyperkalaemia in patients with HFrEF | Proportion of patients with new HFrEF started on RAASi who experienced RAASi dose reduction/withdrawal/prevention of dose uptitration due to hyperkalaemia. | 12 months | |
Primary | Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia | 3. Proportion of hospitalised patients/ED attenders with documented hyperkalaemia, receiving RAASi for prognostic benefit who experience RAASi dose reduction/withdrawal, assessed at discharge | 12 months | |
Secondary | Incidence of repeated episodes of hyperkalaemia | Incidence of repeated episodes of hyperkalaemia after initial episode. | 12 months | |
Secondary | RAASi discontinuation due to other causes rather than hyperkalaemia | Proportion of patients discontinuing RAASi due to other causes than hyperkalaemia (hypotension, worsening renal function, other). | 12 months | |
Secondary | Mortality | Number and causes (all cause, cardiovascular or HF) of mortality at 12 months. | 12 months | |
Secondary | Hospitalisations | Number and causes (all cause, cardiovascular or HF) of hospitalisation at 12 months. | 12 months | |
Secondary | Hyperkalaemia level at which healthcare professionals make changes to RAASi | Level of hyperkalaemia at which healthcare professionals reduce/stop RAASi in patients with and without clear prognostic indications for RAASi. | 12 months | |
Secondary | Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia | Proportion of different grades and specialties of healthcare professionals reducing dose/stopping RAASi in hyperkalaemic patients. | 12 months | |
Secondary | Awareness of RAASi benefits and target doses for patients with HFrEF | Proportion of different grades and specialties of healthcare professionals who are aware of RAASi target doses and benefits in HFrEF. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Completed |
NCT03614169 -
Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB
|
N/A | |
Recruiting |
NCT05278962 -
HF Patients With LVADs Being Treated With SGLT2i
|
Phase 4 | |
Completed |
NCT04210375 -
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
|
Phase 1 | |
Not yet recruiting |
NCT06433687 -
Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
|
||
Completed |
NCT05001165 -
Dashboard Activated Services and Tele-Health for Heart Failure
|
N/A | |
Active, not recruiting |
NCT03701880 -
Early Use of Ivabradine in Heart Failure
|
N/A | |
Recruiting |
NCT05650658 -
Left vs Left Randomized Clinical Trial
|
N/A | |
Not yet recruiting |
NCT06299436 -
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
|
||
Recruiting |
NCT05992116 -
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
|
||
Recruiting |
NCT05365568 -
Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study
|
N/A | |
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Not yet recruiting |
NCT04420065 -
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
|
N/A | |
Terminated |
NCT03479424 -
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
|
||
Completed |
NCT02113033 -
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
|
Phase 2 | |
Recruiting |
NCT03209180 -
Immediate Release Versus Slow Release Carvedilol in Heart Failure
|
Phase 4 | |
Recruiting |
NCT05299879 -
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
|
||
Recruiting |
NCT05637853 -
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
|
||
Completed |
NCT03870074 -
CPET Predicts Long-term Survival and Positive Response to CRT
|
||
Recruiting |
NCT04590001 -
Effect of the MobiusHD® in Patients With Heart Failure
|
N/A |