Evaluating a heart medication in patients starting hemodialysis
Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation
This study is testing if a heart medication can help people who are starting hemodialysis feel better and keep their kidney function longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05498181 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized placebo-controlled study that aims to assess the effects of sacubitril/valsartan on patients who are beginning hemodialysis. The study will focus on measuring echocardiographic indicators of fluid overload, the preservation of remaining kidney function, and various safety parameters. Participants will be monitored closely to determine the medication's efficacy compared to a placebo over the initial stages of hemodialysis treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are initiating hemodialysis within 90 days.
Not a fit: Patients who are anuric or have recently used sacubitril/valsartan may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart health and kidney function in patients starting hemodialysis.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Finnian Mc Causland, MBBCh, MMSc — Brigham and Women's Hospital
- Study coordinator: Finnian R Mc Causland, MBCCh, MMSc
- Email: fmccausland@bwh.harvard.edu
- Phone: 617-732-6432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.