Optimizing medical therapy in patients with heart failure

Phase 1

• Conditions: Heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005176-35-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

For inclusion in the study subjects should fulfil the following criteria:
1.Obtain signed informed consent prior to any study specific procedures
2.>18 yrs, irrespective of sex
3.LVEF = 40%, with echocardiography within last 2 years
4.NYHA II-IV
5.Stable heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge
6.On optimal treatment with GDMT (Guideline-Directed Medical Treatment including ACE/ARB/ARNI and beta blockers) as per physician´s judgement
7.AND one of followings:
(1)Prior hyperkalemia due to MRA therapy and current S-K = 5.0 mmol/L;
(2)Risk of hyperkalemia as indicated by eGFR 30-45 ml/min/1.73m2 and S-K 4.5-5.0 mmol/L;
(3)Mild hyperkalemia (S-K 5.1-5.5 mmol/L) and MRA below target dose (target doses for spironolactone: 25-50 mg daily, and for eplerenone: 50 mg daily)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are ful-filled:
1.Symptomatic hypotension (< 90/60 mmHg)
2.eGFR < 30 ?ml/min/1,73 m2 (modified MDRD formula)
3.HF due to restrictive cardiomyopathy, hypertrophic (obstructive) cardiomy-opathy or primary valvular disease
4.Current/recent (within 3 months) hospitalization due to myocardial infarc-tion, unstable angina pectoris, coronary revascularization (percutaneous cor-onary intervention or coronary artery bypass grafting), or other interventions (valvular repair/replacement, cardiac transplantation or implantation of a ven-tricular assistance device)
5.Ongoing or planned dialysis
6.Prior history of hypersensitivity (other than hyperkalemia) to a MRA, or SZC
7.Advanced malignancy requiring treatment
8.History of QT prolongation associated with other medications that required discontinuation of that medication.
9.Congenital long QT syndrome.
10.Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymp-tomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted
11.QTc(f) > 550 msec
12.Currently pregnant (confirmed with positive pregnancy test) or planned pregnancy or breast-feeding
13.Can not sign informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified