RECRUITING

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

Official Title

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

Quick Facts

Study Start:2022-10-11

Study Completion:2026-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05498181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Finnian R Mc Causland, MBCCh, MMSc

CONTACT

617-732-6432

fmccausland@bwh.harvard.edu

Principal Investigator

Finnian Mc Causland, MBBCh, MMSc

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Finnian Mc Causland, MBBCh, MMSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11

Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-10-11

Study Completion Date2026-07-30

Terms related to this study

Additional Relevant MeSH Terms

Hemodialysis