Clinical trial NCT04760717: Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
Official title: Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Ischemic Stroke
Spironolactone
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.

Detailed description: This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors.

This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year.

Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours.
3. Written, informed consent by patient or surrogate
4. Ability to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

1. Secondary ICH due to trauma, vascular malformation, or tumor
2. Life expectancy \< 1 year
3. eGFR \<45
4. Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment
5. Known hypersensitivity to spironolactone
6. Upper arm greater than 17 inches in circumference
7. Pregnancy, planned pregnancy, or breastfeeding
8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
9. Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization
10. Systolic BP \<120 mmHg at the time of randomization
11. Any condition which, in the judgement of the investigator, increases the risk to the patient
12. History of Addison's disease

Primary outcomes:
measure: Average change in home systolic blood pressure at 3 months
timeFrame: Baseline, 3 month
Secondary outcomes:
measure: Proportion of patients achieving BP < 130/80 mm Hg
timeFrame: 3 months
measure: Number of antihypertensive medications at 3 months
timeFrame: 3 months
measure: Number of antihypertensive medications at 1 year
timeFrame: 1 year
measure: Stroke, myocardial infarction, or death
timeFrame: 1 year
measure: Change in modified Rankin Scale score
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References: