Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The study aims to answer the following research questions: 1. What is the incidence of hyperkalaemia following RAASi therapy initiation and uptitration in patients with a new diagnosis of HFrEF including those with a new diagnosis of post myocardial infarction (MI) left ventricular systolic dysfunction? 2. How does it impact on RAASi prescription? 3. How does hyperkalaemia impact on RAASi therapy according to the clinical indication for the drug(s) in an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia and receiving RAASi? 4. At what level of hyperkalaemia do healthcare professionals consider making changes to RAASi and does it vary according to the clinical indication for the drug(s)? ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04249648
Study type Observational
Source Portsmouth Hospitals NHS Trust
Contact Sarah M Birkhoelzer, Dr
Phone +44 02392 286000
Email sarah.birkhoelzer@gmail.com
Status Recruiting
Phase
Start date July 12, 2021
Completion date April 30, 2025

See also
  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
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
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
Recruiting NCT05072054 - Comparison of Effects of Atorvastatin Versus Rosuvastatin on Cardiac Function in Heart Failure Patients Phase 4
Completed NCT06233695 - Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure