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Clinical Trial NCT07363343 (NEPHRON) for Hypertension, Postpartum Preeclampsia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NEPHRON) 200 Postpartum

Not yet recruiting
Clinical Trial NCT07363343 (NEPHRON) is an interventional study for Hypertension, Postpartum Preeclampsia and is currently not yet recruiting. Enrollment is planned to begin on 1 February 2026 and continue until the study accrues 200 participants. Led by The Cleveland Clinic, this study is expected to complete by 31 December 2029. The latest data from ClinicalTrials.gov was last updated on 23 January 2026.
Brief Summary
To determine if nifedipine and enalapril will have better blood pressure control in the postpartum setting compared to nifedipine and labetalol.
Detailed Description
The primary objective is to assess the efficacy of enalapril on hypertension as a second line agent compared to labetalol in the postpartum period. This is a pragmatic, unblinded, randomized trial of postnatal patients with hypertension who are on nifedipine postpartum and require a second oral agent. Patients will be evaluated for eligibility and consented when they require initiation of a single oral antihypertensi...Show More
Official Title

Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NEPHRON)

Conditions
HypertensionPostpartum Preeclampsia
Other Study IDs
  • NEPHRON
  • 24-918
NCT ID Number
NCT07363343
Start Date (Actual)
2026-02-01
Last Update Posted
2026-01-23
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNifedipine and Enalapril
Nifedipine 60mg by mouth every twelve hours plus Enalapril 5mg by mouth every twelve hours
Nifedipine and Enalapril
Nifedipine 60mg by mouth every twelve hours plus Enalapril 5mg by mouth every twelve hours
Active ComparatorNifedipine and Labetalol
Nifedipine 60mg by mouth every twelve hours plus Labetalol 200mg by mouth every twelve hours
Nifedipine and Labetalol
Nifedipine 60mg by mouth every twelve hours plus Labetalol 200mg by mouth every twelve hours
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Composite postpartum hypertension treatment failure within 6 weeks postpartum
The primary outcome is a binary composite outcome, defined as the occurrence of any one or more of the following events within 6 weeks postpartum: Prolonged hospitalization, Hospital readmission for hypertension, Persistence of hypertension beyond 14 days postpartum, Requirement for acute treatment of severe-range hypertension. Participants experiencing at least one component will be classified as having met the composite outcome.
6-weeks postpartum
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • Postpartum women aged 18 years or older
  • Clinical diagnosis of hypertensive disorder in pregnancy (gestational hypertension, chronic hypertension, preeclampsia with or without severe features)
  • Taking Nifedipine 60 mg every 12 hours for blood pressure control
  • Persistently elevated blood pressure at/above 140/90 mmHg in a 24-hour time period or have one or more severe range blood pressure at/above 160/110 mmHg requiring a second antihypertensive medication
  • English speaking

  • Taking ≥2 antihypertensive agents during pregnancy
  • Heart block
  • Heart rate <60 or >120 beats per minute
  • Heart failure
  • Creatinine >1.5 mg/dL
  • Renal artery stenosis
  • Active connective tissue disease
  • Cerebrovascular accident
  • Failed treatment or contraindications to nifedipine, enalapril or labetalol
The Cleveland Clinic logoThe Cleveland Clinic
Study Central Contact
Contact: Amol Malshe, M.D., 216 903-9646, [email protected]
No location data.