Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium
NCT ID: NCT03682497
Last Updated: 2020-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
68 participants
INTERVENTIONAL
2018-11-01
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spironolactone in the Treatment of Heart Failure
NCT04727073
Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure
NCT02235077
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone
NCT06641284
Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure
NCT04618601
A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
NCT03984591
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spironolactone
Spironolactone treatment for 28 days
Spironolactone
Spironolactone tablets taken orally for 28 days.
AZD9977
AZD9977 treatment for 28 days
AZD9977
AZD9977 capsules taken orally for 28 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD9977
AZD9977 capsules taken orally for 28 days.
Spironolactone
Spironolactone tablets taken orally for 28 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Left ventricular ejection fraction (LVEF) ≥40% by transthoracic echocardiography within the past 12 months
* Plasma NT-proBNP level ≥125 pg/ml (≥ 600pg/mL if patient has persistent or permanent atrial fibrillation, atrial flutter, or atrial tachycardia)
* Estimated glomerular filtration rate (eGFR) ≥40 and ≤70ml/min/1.73m2 (by CKD-EPI formula).
* Baseline serum potassium (sK+) level ≥3.5 and ≤4.8mmol/l.
* Stable doses of the following medications at baseline for at least 4 weeks prior to randomisation:
Angiotensin receptor blocker (ARB) or Angiotensin converting enzyme inhibitor (ACEi) Loop diuretic (up to a 120mg furosemide dose or equivalent
Exclusion Criteria
* Patients experiencing acute decompensation of heart failure requiring hospital admission or escalation in therapy.
* Primary cardiomyopathy (e.g. constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital or any primary cardiomyopathy in judgment of Investigator).
* Hyponatraemia, defined as serum Na+ \<135 mmol/L at the time of enrollment.
* Persistent resting sinus tachycardia \>110 bpm or sinus bradycardia \<45bpm.
* Systolic blood pressure (BP) \<110mmHg or \>180mmHg.
* Diastolic BP \<60 mmHg or \>100 mmHg.
* Patients previously intolerant to MRA (e.g. spironolactone or eplerenone) for any reason.
* Medical conditions associated with development of hyperkalaemia (e.g. Addison's disease).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the upper limit of normal (ULN).
* Patients who have been taking an MR antagonist within 1 month prior to randomization.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Brandýs nad Labem, , Czechia
Research Site
Česká Lípa, , Czechia
Research Site
Jaroměř, , Czechia
Research Site
Louny, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Legnica, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Hull, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D6401C00004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.