Heart Failure
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Heart Failure
D6402C00001 Enrolling

Heart Failure-Kidney Disease Research Trial (22 Weeks)


Treatment: Oral Age: 21 Years

Adults aged 21 years or older with a diagnosis of stable symptomatic heart failure (NYHA class II-III), and a medical history of typical symptoms and signs of heart failure who are currently receiving loop diuretic treatment, may qualify to participate. Individuals must have documented LVEF (left ventricular ejection fraction) below 55% measured within the last 12 months prior to screening. The study is looking for heart failure patients who have chronic kidney disease (with an estimated glomerular filtration rate ≥30 and ≤60 mL/min). Stable background treatment for heart failure, hypertension, diabetes mellitus, or renal disease for at least 3 weeks prior to randomization is required.

Participants will receive oral medication (investigational study drug and dapagliflozin), either in combination, alone or as placebo. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses may be provided.

Length of study participation will last about 22 weeks and involve about 11 visits to the study centre.

Call the study centre near you, or register now.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease

ClinicalTrials.gov ID

NCT04595370

Sponsor

AstraZeneca

Study Description

  • Brief Summary:

    The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60 mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).

  • Condition or Disease:

    Heart Failure

  • Intervention/Treatment:

    Drug: AZD9977
    Drug: AZD9977
    Drug: AZD9977
    Drug: Dapagliflozin
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    21 Years and 130 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Participants are included in the study if any of the following criteria apply:

Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are currently receiving loop diuretic treatment
Left ventricular ejection fraction <60% documented by the most recent echocardiogram or cardiac magnetic resonance imaging within the last 12 months prior to screening Stable background treatment for HF, hypertension, diabetes mellitus or renal disease according to guidelines N-terminal-pro-brain natriuretic peptide (NT proBNP) ≥300 pg/mL for participants with sinus rhythm at screening; and NT proBNP ≥600 pg/mL for participants with atrial fibrillation/flutter at screening The eGFR ≥30 and ≤60 mL/min/1.73^2 (by CKD- EPI formula) and UACR ≥30 mg/g (3 mg/mmol) and <3000 mg/g (300 mg/mmol) Body mass index less than 40 kg/m^2 Serum/plasma K+ level ≥ 3.5 and < 5.0 mmol/L within 10 days prior to randomization Serum/ plasma Na+ level within normal reference values within 10 days prior to randomization Systolic blood pressure should be at protocol defined range at randomization (Visit 3), with no change to antihypertensive treatments in previous 3 weeks Male or female of non-childbearing potential All participants must follow protocol defined contraceptives procedures Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasm antibody-associated vasculitis Participants with currently decompensated HF requiring hospitalization for optimization of HF treatment and are not on stable HF therapy at the time of enrollment HF due to cardiomyopathies High output HF (e.g., due to hyperthyroidism or Paget's disease) HF due to pericardial disease, congenital heart disease or clinically significant uncorrected primary cardiac valvular disease or planned cardiac valve repair/replacement Participants with uncontrolled diabetes mellitus (Glycated hemoglobin >10%)
Participants with Type 1 diabetes mellitus
Intermittent or persistent 2nd or 3rd degree atrioventricular block, sinus node dysfunction with clinically significant bradycardia or sinus pauses, not treated with a pacemaker
History of any life-threatening cardiac dysrhythmia or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter
Acute coronary syndrome and/or elective/non-elective percutaneous cardiac interventions (within 3 months) prior to randomisation or is planned to undergo any of these procedures during the study
Any major cardiovascular (eg, open chest, coronary artery bypass grafting or valvular repair/replacement) or major non-cardiovascular surgery within 3 months prior to randomisation or is planned to undergo any cardiovascular surgery during the study
Heart transplantation or left ventricular assist device at any time or if these are planned
Kidney or any organ transplantation or if these are planned
Medical conditions associated with development of hyperkalaemia (Addison’s disease )
History or ongoing allergy/hypersensitivity, to sodium-glucose co-transporter-2 inhibitor (SGLT2i e.g., dapagliflozin, empagliflozin)
Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within previous 3 months prior to randomisation
Hepatic disease, including hepatitis and/or hepatic impairment (Child-Pugh class A-C), and aspartate aminotransferase or alanine transaminase or total bilirubin should be in protocol defined range at time of screening and/ or within 7 days prior to randomization
Participants with newly detected pathological laboratory values or an ongoing disease condition
If the participants clinical signs and symptoms consistent with COVID-19, and has been previously hospitalized with COVID-19 infection and did not fully recover their previous health status
Previous randomization in the present study
Prior medical treatment with an mineralocorticoid receptor antagonist where the medication was taken within 90 days prior to screening
Current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy, or other immunotherapy


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Michael Hartleib

Cardiologist

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