Clinical Trials Logo

Clinical Trial Summary

A randomized, double-blind, placebo-controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will be conducted at approximately 10 sites in 5 countries. Approximately 96 patients will be randomized to AZD4831 or placebo (treatment duration 90 days).


Clinical Trial Description

This is a randomized, double-blind, placebo controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and mid-range Ejection Fraction (HRmrEF). The study will be conducted at approximately 10 sites in 5 countries (USA, Sweden, Denmark, Finland, Netherlands). Patients suitable for the study will be checked for eligibility, signing the informed consent and enrolled to the study at visit 1. The study will be divided into two parts, Part A and Part B. In part A 37 patients will be randomized at visit 2 in a 2:1 ratio to once daily dosing of AZD4831 or matching placebo for 90 days. After approximately 30 days of treatment, an interim analysis will be done to analyse the safety, tolerability and target engagement. After the evaluation, the recruitment to Part B may proceed. In Part B the remaining 59 patients will be randomized and treated for approximately 90 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03756285
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Status Not yet recruiting
Phase Phase 2
Start date December 7, 2018
Completion date April 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Active, not recruiting NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT03087084 - RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF) N/A
Recruiting NCT03300791 - Predictive Models of Readmission in Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Recruiting NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Recruiting NCT03560167 - Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study N/A
Not yet recruiting NCT03647891 - Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients N/A
Active, not recruiting NCT03281122 - A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction Phase 1
Recruiting NCT02275819 - Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Completed NCT03238729 - Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure N/A
Not yet recruiting NCT03360448 - AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure Phase 3
Not yet recruiting NCT03587064 - Comparison of CRT-D and CRT-DX Systems (CRT-NEXT) N/A
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Recruiting NCT02674438 - Comparison of Outcomes and Access to Care for Heart Failure Trial Phase 3
Recruiting NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02911493 - Reducing Sedentary Time in Patients With Heart Failure N/A
Recruiting NCT02877914 - China PEACE 5r-HF Study N/A
Recruiting NCT02713126 - Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) Phase 2