Swedish Cardiac And Renal Failure Study-1
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
Previous studies have shown that patients with heart failure with reduced pumping function and preserved kidney function experience improved symptoms, longer survival, and fewer hospitalizations when treated with medications such as eplerenone. However, individuals with impaired kidney function have been excluded from these trials due to concerns about potential adverse effects on potassium levels, kidney function, and possibly also blood pressure. As a result, clear treatment recommendations for this high-risk group are lacking.
In recent years, however, background therapies have been modernized and are now associated with a lower risk of potassium disturbances. Preliminary data also suggest that patients with impaired kidney function may benefit from eplerenone treatment. However, confirmation through dedicated studies is needed.
The primary objective of this pilot trial is to assess the feasibility and safety of eplerenone in patients with heart failure with reduced pumping function and impaired kidney function. Treatment effectiveness will also be explored.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant has given their written consent to participate
A diagnosis of HFrEF according to current criteria, for at least three months before the screening visit
Echocardiography within 24 months of the screening visit with ejection fraction ≤ 40%. The responsible investigator is allowed to order a new TTE at their own discretion if clinically indicated - e.g. following the initiation of markedly intensified HFrEF-treatment or in the event of significant clinical deterioration. If the new TTE shows an EF > 40%, the participant will not be eligible for inclusion. However, a potential echocardiographic worsening should not, by itself, preclude enrollment
New York Heart Association class II-III
Disqualifiers
P-K ≥ 5.6
Ongoing/planned dialysis
Systolic blood pressure < 90 mmHg
Uncontrolled hypertension as judged by the investigator
Trial design
Design model
Single group
Treatments tested in this trial
Eplerenone
DrugParticipants will receive eplerenone 25 mg once daily or every other day, based on baseline potassium levels, eGFR, systolic blood pressure, and concomitant use of weak or moderate CYP3A4 inhibitors. The study will implement a safety protocol with predefined procedures for managing significant hyperkalemia, worsening renal function, and hypotension. These will include temporary or permanent dose reduction or discontinuation of eplerenone, and, if necessary, administration of the potassium binder sodium zirconium cyclosilicate (SZC, Lokelma®).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Single-armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary endpoint is the proportion of participants who complete the treatment period with and without the need to use a potassium binder
Without eplerenone interruption/discontinuation due to safety reasons, with and without SZC
Time frame
Between the first and final day of the 12-week eplerenone treatment periodSecondary outcomes
1
The occurrence of plasma potassium (P-K) ≥ 5.6 and ≥ 6.0
Yes/no
Time frame
Between the first and final day of each of the three 12-week study periods2
Hospitalization for hyperkalemia
Primary or co-primary reason, yes/no
Time frame
Between the first and final day of each of the three 12-week study periods3
The occurrence of P-K < 3.0
Yes/no
Time frame
Between the first and final day of each of the three 12-week study periods4
Hospitalization for hypokalemia
Primary or co-primary reason, yes/no
Time frame
Between the first and final day of each of the three 12-week study periodsOther outcomes
1
Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score
Overall summary score between 0 and 100 (0 = very poor health status and 100 = excellent health status)
Time frame
At the end of the 12-week eplerenone treatment period, compared with the scores at the end of the 12-week baseline period and the end of the 12-week withdrawal period2
Six-Minute Walk Test (6MWD)
Meters walked during six minutes
Time frame
At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period3
N-terminal pro b-type natriuretic peptide (NTpro-BNP)
in ng/L
Time frame
At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period4
eGFR
According to the revised Lund-Malmö method in ml/min/1.73 m2
Time frame
At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal periodSponsors and contacts
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Source ClinicalTrials.gov