Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg for Heart Failure and Impaired Kidney Function
This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to measure the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, or dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin. The registry lists allocation as randomized. This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event.
They plan to enroll about 3,850 people at 656 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
Primary outcome (registry wording): Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Who it is for (from inclusion criteria)
Ages 18 Years to 130 Years
Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
Having had a recent HF event within 6 months (hospitalization or urgent visit)
Have a LVEF value from an assessment within the last 12 months
Managed with SoC therapy for HF and renal impairment according to local guidelines
NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
Serum/plasma potassium ≤ 5.0 mmol/L
Who the registry excludes
Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
History of hypertrophic obstructive cardiomyopathy
Complex congenital heart disease or severe uncorrected primary valvular disease
Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours
Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers.
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to measure the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06307652?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06307652?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.