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Could a heart pill protect kidneys in new dialysis patients?

NCT ID NCT05498181

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called sacubitril/valsartan (a heart failure medication) in 45 adults who had just started hemodialysis. The goal was to see if it could improve heart function and help preserve any remaining kidney function compared to a placebo. Participants took the drug or placebo for 16 weeks while continuing their regular dialysis.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Started

Oct 2022

Finished

Jan 2026

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.

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: * Adults ≥18 years initiating HD (within 90 days of first HD session) * Thrice-weekly HD * Informed consent * Hemodynamically Stable: Sitting pre-dialysis SBP ≥110 mmHg averaged over prior two weeks or at the baseline visit; no symptomatic hypotension in prior two weeks; no use of midodrine. * Has not taken an ACEi for 36 hours prior to randomization Exclusion Criteria: * Anuria (daily urine volume \<100 mL/day) * Current or any use of sacubitril/valsartan within the past 30 days * History of hypersensitivity or intolerance to any of the study drugs, including ARBs or sacubitril/valsartan * Angioedema related to previous ACE inhibitor, ARB, or ARNI therapy * Serum potassium \>5.5 mEq/L at screening (pre-HD if already on HD) * Acute coronary syndrome, stroke, TIA, major CV surgery, percutaneous coronary intervention or carotid angioplasty within one month * Intended coronary or carotid revascularization within 4 months * Implantation of a cardiac resynchronization therapy device (CRTD) within 3 months or intent to implant a CRTD * History of heart transplant, or planned heart transplant, or with left ventricular assist device * Planned renal transplant within 4 months * Documented untreated ventricular arrhythmia with syncopal episodes within 3 months * Symptomatic bradycardia or 2nd or 3rd degree heart block without a pacemaker * Presence of hemodynamically significant valvular disease or hypertrophic cardiomyopathy or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis) * History of malignancy of any organ system within the past year (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence) * Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis with evidence of portal hypertension); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease * Pregnant (positive hCG test) or lactating women * Enrollment in another interventional trial * Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline * Does not have capacity to consent (Folstein mini-mental score of 23 or less) * Any condition that in the opinion of the investigator would make participation not in the best interest of the subject * Women of child-bearing age, unless using two birth control methods. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug.

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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.

Contacts and locations

Locations

  • Brigham and Women's

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.