Spironolactone for Hypertension

(IMPACT-HT Trial)

Recruiting at 2 trial locations

Overseen By Michael C Honigberg, MD, MPP

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: Antihypertensives

Must not be taking: Eplerenone, Finerenone

Disqualifiers: Heart failure, Diabetes, Cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if spironolactone can lower blood pressure and improve heart health in women who experienced high blood pressure during pregnancy. Researchers believe that blocking a specific receptor might prevent long-term heart issues after such pregnancies, particularly in women who were overweight before pregnancy. Women who had pregnancy-related high blood pressure and required medication after delivery might be suitable candidates. Participants will take either spironolactone or a placebo for three months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using eplerenone or finerenone.

Is there any evidence suggesting that spironolactone is likely to be safe for humans?

Research has shown that spironolactone is generally safe for treating heart failure and high blood pressure in adults who are not pregnant. Most people do not experience serious side effects. Common mild side effects include dizziness, headache, and upset stomach.

However, spironolactone is usually not recommended during pregnancy due to insufficient studies on its safety for pregnant women. Although past reports have not indicated major problems during pregnancy, caution remains important.

This trial is a phase 2 study, indicating that spironolactone has demonstrated some safety in earlier research, but more information is needed to fully understand its safety for this specific use. Participants should always discuss the risks and benefits with their doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Spironolactone is unique because it targets aldosterone, a hormone that can contribute to high blood pressure, especially in hypertensive disorders of pregnancy. Unlike standard treatments like methyldopa or labetalol, which primarily work by relaxing blood vessels or slowing the heart rate, spironolactone acts as an aldosterone antagonist, potentially offering a new mechanism to manage hypertension. Researchers are excited about spironolactone because it may offer a more targeted approach, addressing the hormonal imbalance that can drive blood pressure issues in pregnant individuals, with the potential for fewer side effects.

What evidence suggests that spironolactone might be an effective treatment for hypertension?

Research has shown that spironolactone lowers blood pressure by blocking a specific receptor that controls the body's salt and water levels. This makes it a common treatment for high blood pressure. Spironolactone has generally been effective in managing high blood pressure and improving outcomes in various heart-related conditions. In this trial, participants will receive either spironolactone or a placebo to evaluate its effectiveness specifically for high blood pressure after childbirth. Although limited data exists for high blood pressure after childbirth, spironolactone's ability to address blood pressure issues offers hope for women who experienced high blood pressure during pregnancy. However, it is usually not recommended during pregnancy because it might affect the baby's development. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women who have had high blood pressure during pregnancy, specifically those with conditions like preeclampsia or gestational hypertension. It's especially focused on women who were overweight before pregnancy and are at risk of long-term heart issues.

Inclusion Criteria

I am a woman aged 18 or older.

Ability to provide informed consent

Antepartum-onset hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension

Exclusion Criteria

Intention to become pregnant within 9 months

Participation in another interventional clinical study

Hypersensitivity to spironolactone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either spironolactone or placebo for 12 weeks postpartum

12 weeks

Baseline, 2 weeks, 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure and cardiac remodeling assessments

24 weeks

36 weeks post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Spironolactone

Trial Overview The study tests if taking spironolactone (a drug that blocks certain hormone receptors) after giving birth can help lower blood pressure and improve heart health by nine months postpartum. Participants will either receive spironolactone or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Treatment: Spironolactone Experimental Treatment 1 Intervention

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.

Group II: Placebo: Control Placebo Group 1 Intervention

Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4558097/

Drug Treatment of Hypertension in Pregnancy - PMC C, Safety similar to methyldopa. Limited data regarding fetal safety ... Spironolactone is not recommended due to potential fetal antiandrogen effects.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07041281

Study Details | NCT07041281 | Spironolactone to Improve ... Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect ...

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1404251/full

Case report: A pregnant woman accidental treated with ... This single case shows that pregnant women exposed to spironolactone in early and mid-gestation may not be at as high a risk as previously thought on animal ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf

ALDACTONE® (spironolactone) tablets for oral use Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07041281

Study Details | NCT07041281 | Spironolactone to Improve ... Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306061/

Case report: A pregnant woman accidental treated with ... Our case study aims to provide valuable reference data on spironolactone exposure during pregnancy, aiding patients and healthcare providers in making ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884655/

Primary aldosteronism in pregnancy - PMC In conclusion spironolactone is routinely contraindicated during pregnancy due to the lack of evidence on its safety in controlled trials and ...