PreeclampsiaPhase 2IMPACT-HTNCT07041281
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
A Phase 2 study testing spironolactone 25 mg orally once daily in people with Preeclampsia and Gestational Hypertension, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The hypertensive disorders of pregnancy (preeclampsia and gestational hypertension) are associated with increased long-term maternal risk of developing cardiovascular disease. Recent evidence suggests that activation of the mineralocorticoid receptor promotes ongoing susceptibility to hypertension in women following… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Gestational Hypertension
- What is being tested?
- spironolactone 25 mg orally once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Oct 2025to 2 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged ≥18 years
- HDP (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension
- BMI ≥25 kg/m2 prior to pregnancy or in the first trimester
- Requirement for antihypertensive medication within one week of delivery
- Ability to provide informed consent
Who cannot join
- LV ejection fraction <50% or history of clinical heart failure with reduced or preserved ejection fraction
- Hypertrophic or other genetic cardiomyopathy
- Hyperkalemia: potassium >5.3 mEq/L
- BMI at screening ≥50 kg/m2
- Pre-pregnancy diabetes
- Estimated glomerular filtration rate (eGFR) <60mL/min/1.73 m2
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- Cirrhosis
- Primary aldosteronism
- Intention to become pregnant within 9 months
- Active substance abuse
- Other serious medical illnesses or concerns about protocol adherence/ mortality within 9 months
- Participation in another interventional clinical study
- Hypersensitivity to spironolactone
- Addison's disease
- Concomitant use of eplerenone or finerenone
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Victoria R Viscosi, MS, 617-724-2996, vviscosi@mgh.harvard.edu
Michael C Honigberg, MD, MPP
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Maria A. Pabon, MD, 857-407-4561, mpabonporras@bwh.harvard.edu
- Not yet recruiting
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Malamo E Countouris, MD, MS, 412-569-4229, countourisme@upmc.edu
About this study
The hypertensive disorders of pregnancy (preeclampsia and gestational hypertension) are associated with increased long-term maternal risk of developing cardiovascular disease. Recent evidence suggests that activation of the mineralocorticoid receptor promotes ongoing susceptibility to hypertension in women following hypertensive disorders of pregnancy. In addition, women with overweight/obesity are at increased risk for progression to chronic hypertension after experiencing hypertensive disorders of pregnancy. Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect of pharmacologically blocking the mineralocorticoid receptor for three months after delivery on blood pressure and cardiac remodeling at nine months postpartum.
Read the detailed description
The hypertensive disorders of pregnancy (HDP, e.g., gestational hypertension and preeclampsia) are a leading cause of maternal and infant morbidity and mortality and are associated with increased long-term risk of maternal atherosclerotic cardiovascular disease (CVD) and heart failure. The American College of Cardiology and American Heart Association now recognize the HDP as a sex-specific CVD risk factor to guide prescription of preventive statin therapy. Beyond this focused recommendation, however, targeted strategies for CVD risk reduction in women with HDP are not yet established. Maternal overweight/obesity is a risk factor for accelerated progression from HDP to chronic hypertension, a key mediator of heightened long-term CVD risk in women with a history of HDP, and for adverse cardiac remodeling in pregnancy. Recent preclinical evidence suggests that the HDP induce heightened vascular smooth muscle cell mineralocorticoid receptor (MR) sensitivity that persists postpartum, promoting chronic hypertension and CVD. In addition, the recent POP-HT trial suggested that blood pressure control in the very early postpartum period has long-lasting effects on the risk of chronic hypertension and cardiac remodeling in women after HDP. Integrating these lines of evidence, the investigators hypothesize that short-term pharmacologic blockade of the MR in the early postpartum period after HDP will yield long-term maternal cardiovascular benefits in women with overweight/obesity. To test this hypothesis, the investigators will compare a strategy of adding low-dose spironolactone, a breastfeeding-compatible MR antagonist, or placebo to usual care for 3 months following delivery with HDP. This multi-site trial will randomize 204 women with HDP and pre-pregnancy overweight/obesity delivering at Massachusetts General Hospital, Brigham and Women's Hospital, and the University of Pittsburgh-Magee Womens Hospital. The investigators will test the effect of short-term adjunctive postpartum spironolactone on 24-hour ambulatory blood pressure (Aim 1) and postpartum cardiac remodeling by echocardiography (Aim 2) at 9 months postpartum (i.e., 6 months after completion of study treatment).
- Conditions
- Preeclampsia, Gestational Hypertension
- Being tested
- spironolactone 25 mg orally once daily, Placebo tablet to match spironolactone
- Keywords
- preeclampsia, gestational hypertension, spironolactone, blood pressure, hypertension, pregnancy, echocardiography
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactone 25 mg orally once dailyDrug
Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment.
Placebo tablet to match spironolactoneDrug
Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo: Control | Placebo comparator | Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment. Receives: Drug: Placebo tablet to match spironolactone |
| Treatment: Spironolactone | Experimental | Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment. Receives: Drug: spironolactone 25 mg orally once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour ambulatory diastolic blood pressure
24-hour BP monitoring will be performed as part of end-of-study assessments using a validated ambulatory BP monitor.
Measured: 36 weeks
Secondary outcomes (31)
Left ventricular relative wall thickness (main echocardiographic outcome)
Relative wall thickness is calculated as 2*posterior wall thickness/LV end-diastolic diameter as measured by transthoracic echocardiography.
Measured: Baseline and 36 weeks
Mean 24-hour ambulatory systolic blood pressure
24-hour BP monitoring will be performed as part of end-of-study assessment using a validated ambulatory BP monitor. Mean 24-hour systolic BP will be calculated from the device data.
Measured: 36 weeks
Mean diurnal ambulatory systolic blood pressure
24-hour BP monitoring will be performed as part of the end-of-study assessment using a validated ambulatory BP monitor. Mean diurnal systolic BP will be calculated from the device data.
Measured: 36 weeks
Mean diurnal ambulatory diastolic blood pressure
24-hour BP monitoring will be performed as part of the end-of-study assessment using a validated ambulatory BP monitor. Mean diurnal ambulatory diastolic blood pressure will be calculated from the device data
Measured: 36 weeks
Mean nocturnal ambulatory systolic blood pressure
24-hour BP monitoring will be performed as part of the end-of-study assessment using a validated ambulatory BP monitor. Mean nocturnal ambulatory systolic blood pressure will be calculated from the device data.
Measured: 36 weeks
Mean nocturnal ambulatory diastolic blood pressure
24-hour BP monitoring will be performed as part of the post-treatment assessments using a validated ambulatory BP monitor. Mean nocturnal ambulatory diastolic blood pressure will be calculated from the device data.
Measured: 36 weeks
Measured systolic blood pressure
At each visit, BP will be measured by study staff three times at one-minute intervals in accordance with multi-society guidelines for accurate measurement of blood pressure. The first measurement will be discarded, and the average of the second and third measurements will be recorded as the measured BP at each study visit.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Measured diastolic blood pressure
At each visit, BP will be measured by study staff three times at one-minute intervals in accordance with multi-society guidelines for accurate measurement of blood pressure. The first measurement will be discarded, and the average of the second and third measurements will be recorded as the measured BP at each study visit.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Readmission for hypertension
Postpartum readmission for hypertension will be captured.
Measured: Through study completion (36 weeks post-randomization)
All-cause readmission
All postpartum readmission will be captured
Measured: Through study completion (36 weeks post-randomization)
Daily defined doses of antihypertensive medication
Daily defined doses of antihypertensive medication will be quantified in accordance with the World Health Organization classification.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Time to discontinuation of all non-study drug antihypertensive medications
All medication changes made by treating clinicians will be captured.
Measured: Through study completion (36 weeks post-randomization)
Escalation of antihypertensive regimen
All medication changes made by treating clinicians will be captured.
Measured: Through study completion (36 weeks post-randomization)
Ratio of mitral E velocity to e' [E/e']
E/e', a measure of diastolic function, will be measured by transthoracic echocardiography.
Measured: Baseline and 36 weeks
Early diastolic septal mitral annular velocity [septal e']
Septal e', a measure of diastolic function, will be measured by transthoracic echocardiography using tissue Doppler
Measured: Baseline and 36 weeks
Peak tricuspid regurgitant jet velocity
Peak tricuspid regurgitant jet velocity, a measure of diastolic function, will be measured by transthoracic echocardiography using continuous wave Doppler
Measured: Baseline and 36 weeks
Left atrial volume index
Left atrial volume index will be measured by transthoracic echocardiogarphy using the biplane method and indexed for body surface area.
Measured: Baseline and 36 weeks
Ratio of E to A [E/A]
E/A, a measure of diastolic function, will be measured by transthoracic echocardiography.
Measured: Baseline and 36 weeks
Left ventricular mass index
Left ventricular mass will be calculated from transthoracic echocardiogarphy using the Devereux formula and indexed for body surface area
Measured: Baseline and 36 weeks
Left ventricular ejection fraction
Left ventricular ejection fraction will be measured by transthoracic echocardiogarphy using the biplane method.
Measured: Baseline and 36 weeks
Left atrial reservoir strain
Left atrial strain, a sensitive measure of end- diastolic pressure and atrial remodeling, will be quantified using TOMTEC.
Measured: Baseline and 36 weeks
Peak global longitudinal strain
Left ventricular global longitudinal strain, a measure of subclinical cardiac dysfunction, will be quantified using TOMTEC.
Measured: Baseline and 36 weeks
Interventricular septal wall thickness
Interventricular septal wall thickness will be measured by transthoracic echocardiography from the parasternal long axis view.
Measured: Baseline and 36 weeks
Posterior wall thickness
Posterior wall thickness will be measured by transthoracic echocardiography from the parasternal long axis view.
Measured: Baseline and 36 weeks
High-sensitivity cardiac troponin I
High-sensitivity cardiac troponin will be measured using standard clinical assays.
Measured: Baseline, 12 weeks, and 36 weeks
N-terminal pro-B-type natriuretic peptide
NT-proBNP will be measured using standard clinical assays.
Measured: Baseline, 12 weeks, and 36 weeks
Urine microalbumin/creatinine
Urine microalbumin/creatinine will be measured using standard clinical assays.
Measured: 2 weeks, 12 weeks, and 36 weeks
Activin A
Activin A will be measured by ELISA.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Soluble fms-like tyrosine kinase receptor-1
sFlt-1 will be measured by ELISA.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Placental growth factor
Placental growth factor will be measured by ELISA.
Measured: Baseline, 2 weeks, 12 weeks, and 36 weeks
Procollagen type I carboxyterminal propeptide
PICP will be measured by enzyme immunoassay.
Measured: Baseline, 12 weeks, and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start16 Oct 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, placebo-controlled trial of low-dose spironolactone versus placebo in women with pre-pregnancy overweight/obesity who develop de novo hypertensive disorders of pregnancy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Michael C. Honigberg, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041281
- Sponsor's protocol ID
- 2025P001195
- Other IDs
- 25SFRNPCKMS1463898, STUDY25060149
- Acronym
- IMPACT-HT
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
- ClinicalTrials.gov ID
- NCT07041281
- Acronym / sponsor ID
- IMPACT-HT / 2025P001195
- Conditions
- Preeclampsia, Gestational Hypertension
- Keywords
- preeclampsia, gestational hypertension, spironolactone, blood pressure, hypertension, pregnancy, echocardiography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Pittsburgh Medical Center
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Mar 2029 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypertensive disorders of pregnancy (preeclampsia and gestational hypertension) are associated with increased long-term maternal risk of developing cardiovascular disease. Recent evidence suggests that activation of the mineralocorticoid receptor promotes ongoing susceptibility to hypertension in women following hypertensive disorders of pregnancy. In addition, women with overweight/obesity are at increased risk for progression to chronic hypertension after experiencing hypertensive disorders of pregnancy. Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect of pharmacologically blocking the mineralocorticoid receptor for three months after delivery on blood pressure and cardiac remodeling at nine months postpartum.
Detailed description
The hypertensive disorders of pregnancy (HDP, e.g., gestational hypertension and preeclampsia) are a leading cause of maternal and infant morbidity and mortality and are associated with increased long-term risk of maternal atherosclerotic cardiovascular disease (CVD) and heart failure. The American College of Cardiology and American Heart Association now recognize the HDP as a sex-specific CVD risk factor to guide prescription of preventive statin therapy. Beyond this focused recommendation, however, targeted strategies for CVD risk reduction in women with HDP are not yet established. Maternal overweight/obesity is a risk factor for accelerated progression from HDP to chronic hypertension, a key mediator of heightened long-term CVD risk in women with a history of HDP, and for adverse cardiac remodeling in pregnancy. Recent preclinical evidence suggests that the HDP induce heightened vascular smooth muscle cell mineralocorticoid receptor (MR) sensitivity that persists postpartum, promoting chronic hypertension and CVD. In addition, the recent POP-HT trial suggested that blood pressure control in the very early postpartum period has long-lasting effects on the risk of chronic hypertension and cardiac remodeling in women after HDP. Integrating these lines of evidence, the investigators hypothesize that short-term pharmacologic blockade of the MR in the early postpartum period after HDP will yield long-term maternal cardiovascular benefits in women with overweight/obesity. To test this hypothesis, the investigators will compare a strategy of adding low-dose spironolactone, a breastfeeding-compatible MR antagonist, or placebo to usual care for 3 months following delivery with HDP. This multi-site trial will randomize 204 women with HDP and pre-pregnancy overweight/obesity delivering at Massachusetts General Hospital, Brigham and Women's Hospital, and the University of Pittsburgh-Magee Womens Hospital. The investigators will test the effect of short-term adjunctive postpartum spironolactone on 24-hour ambulatory blood pressure (Aim 1) and postpartum cardiac remodeling by echocardiography (Aim 2) at 9 months postpartum (i.e., 6 months after completion of study treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, placebo-controlled trial of low-dose spironolactone versus placebo in women with pre-pregnancy overweight/obesity who develop de novo hypertensive disorders of pregnancy
| Arm | Type | Receives |
|---|---|---|
| Placebo: Control | Placebo comparator | Drug: Placebo tablet to match spironolactoneParticipants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment. |
| Treatment: Spironolactone | Experimental | Drug: spironolactone 25 mg orally once dailyParticipants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females aged ≥18 years
- HDP (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension
- BMI ≥25 kg/m2 prior to pregnancy or in the first trimester
- Requirement for antihypertensive medication within one week of delivery
- Ability to provide informed consent
Key exclusion criteria (15 listed)
- LV ejection fraction <50% or history of clinical heart failure with reduced or preserved ejection fraction
- Hypertrophic or other genetic cardiomyopathy
- Hyperkalemia: potassium >5.3 mEq/L
- BMI at screening ≥50 kg/m2
- Pre-pregnancy diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spironolactone 25 mg orally once dailyParticipants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment. | Drug | Treatment: Spironolactone |
| Placebo tablet to match spironolactoneParticipants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment. | Drug | Placebo: Control |
Primary outcome
Mean 24-hour ambulatory diastolic blood pressure
Time frame: 36 weeks
24-hour BP monitoring will be performed as part of end-of-study assessments using a validated ambulatory BP monitor.
31 secondary outcomes
Left ventricular relative wall thickness (main echocardiographic outcome)
Time frame: Baseline and 36 weeks
Mean 24-hour ambulatory systolic blood pressure
Time frame: 36 weeks
Mean diurnal ambulatory systolic blood pressure
Time frame: 36 weeks
Mean diurnal ambulatory diastolic blood pressure
Time frame: 36 weeks
Mean nocturnal ambulatory systolic blood pressure
Time frame: 36 weeks
Mean nocturnal ambulatory diastolic blood pressure
Time frame: 36 weeks
Measured systolic blood pressure
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Measured diastolic blood pressure
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Readmission for hypertension
Time frame: Through study completion (36 weeks post-randomization)
All-cause readmission
Time frame: Through study completion (36 weeks post-randomization)
Daily defined doses of antihypertensive medication
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Time to discontinuation of all non-study drug antihypertensive medications
Time frame: Through study completion (36 weeks post-randomization)
Escalation of antihypertensive regimen
Time frame: Through study completion (36 weeks post-randomization)
Ratio of mitral E velocity to e' [E/e']
Time frame: Baseline and 36 weeks
Early diastolic septal mitral annular velocity [septal e']
Time frame: Baseline and 36 weeks
Peak tricuspid regurgitant jet velocity
Time frame: Baseline and 36 weeks
Left atrial volume index
Time frame: Baseline and 36 weeks
Ratio of E to A [E/A]
Time frame: Baseline and 36 weeks
Left ventricular mass index
Time frame: Baseline and 36 weeks
Left ventricular ejection fraction
Time frame: Baseline and 36 weeks
Left atrial reservoir strain
Time frame: Baseline and 36 weeks
Peak global longitudinal strain
Time frame: Baseline and 36 weeks
Interventricular septal wall thickness
Time frame: Baseline and 36 weeks
Posterior wall thickness
Time frame: Baseline and 36 weeks
High-sensitivity cardiac troponin I
Time frame: Baseline, 12 weeks, and 36 weeks
N-terminal pro-B-type natriuretic peptide
Time frame: Baseline, 12 weeks, and 36 weeks
Urine microalbumin/creatinine
Time frame: 2 weeks, 12 weeks, and 36 weeks
Activin A
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Soluble fms-like tyrosine kinase receptor-1
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Placental growth factor
Time frame: Baseline, 2 weeks, 12 weeks, and 36 weeks
Procollagen type I carboxyterminal propeptide
Time frame: Baseline, 12 weeks, and 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing spironolactone 25 mg orally once daily in people with Preeclampsia and Gestational Hypertension, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael C Honigberg, MD, MPP (617-726-1843, mhonigberg@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour ambulatory diastolic blood pressure (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.