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Heart failure study to uncover hidden links to kidney and liver disease

NCT ID NCT07380828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 3000 adults with chronic heart failure to see how often they also have kidney disease, diabetes, fatty liver, or clogged arteries. Researchers want to understand how these conditions interact and affect patient outcomes over two years. No new treatments are being tested; the goal is to gather knowledge for better future care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict and manage heart failure by understanding how it connects with other conditions like kidney disease and diabetes.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any new drug or therapy, so it may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will include patients with pre-existing or clinically evident CHF at the outpatient stage or in hospital, provided that their condition is stabilized and there has been no intravenous therapy with diuretics, nitrates, vasopressors or inotropes during the previous 24 hours.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years; 2. A diagnosis that satisfies one of the following criteria: * At least one of the following: LVEF \<50%, LV longitudinal systolic strain (GLS) \<18%, NT-proBNP \>125 pg/mL in sinus rhythm or 365 in AF/AT, E/é \>9 at rest by tissue Doppler, Indexed left ventricular volume (ILV) \>34 mL/m2 in sinus rhythm or 40 mL/m2 in AF/AT, Tricuspid regurgitation (TR) velocity \>2.8 m/s or pulmonary artery systolic pressure (PASP) \>35 mmHg. at rest, Left ventricular myocardial mass index (LVMI) \>115/95 g/m2 in men/women and relative wall thickness (RWT) \>0.42, in the absence of symptoms and/or signs of current or past CHF, which corresponds to "pre-CHF" in accordance with the 2024 clinical guidelines. or * LVEF \<50% and the presence of symptoms and/or signs of current or past CHF or * LVEF ≥50% and the presence of symptoms and/or signs of current or past CHF, as well as at least one of the following (A, B, C) criteria: A. Presence of one of the signs of structural and/or functional heart disorders consistent with the presence of diastolic dysfunction / elevated left ventricular filling pressure: 1. . NT-proBNP level \>200 pg/mL in sinus rhythm or \>600 pg/mL in AF/AT, 2. . E/é \>13 at rest by tissue Doppler, 3. . 13 ≥E/é \>9 + left atrial dilation (LAD) \>34 ml/m2 in sinus rhythm or \>40 ml/m2 in AF/AT, 4. . 13 ≥E/é \>9 + TR velocity \>2.8 m/s or PASP \>35 mmHg at rest, 5. . 13 ≥E/é \>9 + presence of left ventricular hypertrophy, defined as LVMI \>115 g/m2 in men and \>95 g/m2 in women, WCT \>0.42, OR B. Presence of 7-9 points on the H2FPEF scale; OR C. Positive diastolic stress test result confirming increased LV filling pressure (E/e'≥15, TR velocity \>3.4 m/s) 3. No intravenous therapy with diuretics, nitrates, vasopressors, or inotropes within 24 hours prior to inclusion; 4. Availability of results of all of the following tests, performed no earlier than in the previous 6 months prior to inclusion in the study: \[1\] Complete blood count with hemoglobin and platelet levels, \[2\] Blood chemistry with total bilirubin, ALT, and AST levels, \[3\] Serum uric acid and creatinine levels, with glomerular filtration rate (eGFR) calculation using the 2021 CKD-EPI formula, \[4\] Fasting glucose and HbA1c, and, if the diagnosis is uncertain, an oral glucose tolerance test, \[5\] Ultrasound of the carotid and/or femoral arteries (only in patients with no prior history of atherosclerotic cardiovascular disease), \[6\] Urine test for CKD markers - at least one of the following: daily albuminuria (mg/day) and/or albumin/creatinine ratio in a single urine portion (mg/g or mg/mmol) and/or daily proteinuria (g/day) and/or protein/creatinine ratio in a single urine portion (mg/g or mg/mmol). - Exclusion Criteria: * 1\. Current participation in a randomized clinical trial; 2. Confirmed or suspected diagnosis of an alternative or comorbid condition that, in the opinion of the investigator, may explain the patient's symptoms and signs of CHF; 3. History of heart transplantation, combined congenital heart disease, or the presence of a mechanical circulatory support device; 4. Cardiac tamponade; 5. Pregnancy and lactation, planning a pregnancy in the next 24 months; 6. Acute cerebrovascular accident, transient ischemic attack, acute coronary syndrome, or coronary revascularization within less than 30 days prior to or on the day of study inclusion; 7. Acute dysfunction or failure of one or more internal organs within 3 months prior to or on the day of inclusion; 8. Any cardiac surgery performed within 3 months prior to enrollment or planned within the next 6 months, including implantation of intracardiac devices, ablation for cardiac arrhythmias, or correction of valvular pathology; 9. Severe cognitive impairment or other conditions that, in the opinion of the investigator, prevent the patient from understanding the program, providing informed consent, or interfere with participation in the study; 10. Active cancer; 11. Verified cardiac amyloidosis or other infiltrative cardiomyopathy (hemochromatosis, Fabry disease, Gaucher disease); 12. Verified hereditary cardiomyopathy; 13. Heart disease due to reversible causes (e.g., Takotsubo syndrome).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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