TerminatedPhase 1

AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment

Stopped: The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.

Sweden10 participantsStarted 2024-10-15

Plain-language summary

The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR (30 to 90 mL/min/1.73m2).

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Postmenopausal, defined as amenorrhoea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with FSH levels in the postmenopausal range.
✓. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilisation.

Exclusion criteria

✕. Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, percutaneous coronary intervention, implantable cardioverter defibrillator implantation, within 12 weeks prior to screening.
✕. Primary cardiomyopathy other than dilated, including but not limited to sarcoidosis, amyloidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, complex congenital heart disease.
✕. Sitting SBP \> 160 mmHg or sitting DBP \> 110 mmHg after a period of at least 5 minutes of rest;
✕. Sitting SBP \< 100 mmHg or sitting DBP \< 50 mmHg;
✕. Resting pulse rate of \< 50 bpm or \> 115 bpm.

What they're measuring

The volumetric fraction (%) of the renal cortex with increased perfusion from baseline to Day 8, compared to placebo.

Timeframe: Baseline to Day 8

Trial details

NCT IDNCT06611423

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-21

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction (HFrEF) trials