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Safety and Procedure efficacy of Renal denervation In pre-pregnancy hyperteNsion: a prospective, single-center, Gauging pilot study(SPRING-I)

Safety and Procedure efficacy of Renal denervation In pre-pregnancy hyperteNsion: a prospective, single-center, Gauging pilot study(SPRING-I)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107230
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-08-11
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

Nulligravid Pre-Pregnancy Intervention Group:RDN Surgery + Hypertension Drugs
Nulligravid Pre-Pregnancy Control Group:Hypertension Drugs
Nulligravid Pre-Pregnancy Control Group:RDN Surgery + Hypertension Drugs
Nulligravid Pre-Pregnancy Intervention Group:Hypertension Drugs

Sponsors

The West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.The individual is >=18 years of age and =160 mmHg; 4.For female patients planning pregnancy, pregnancy is contraindicated due to inadequate blood pressure control; 5.The patient has a confirmed diagnosis of hypertension; 6.The individual agrees to perform all study procedures and is willing and able to provide written informed consent to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1.Unsuitable renal artery anatomy for treatment, including: (1) Main renal artery diameter 50% or renal artery aneurysm in any renal artery; (4) History of prior renal artery intervention, including balloon angioplasty or stenting; (5) Functionally single kidney. 2.Patient hospitalized >=1 time for hypertensive crisis within the past year. *Hypertensive Crisis Definition: Severe elevation in blood pressure (BP), typically >180/110 mmHg, accompanied by progressive or imminent target organ damage, requiring hospitalization (often in an intensive care unit [ICU]) for management (e.g., with intravenous [IV] antihypertensive agents), unrelated to confirmed medication non-adherence.* 3.Patient with 24-hour average systolic blood pressure =1 episode(s) of symptomatic orthostatic hypotension (decrease in systolic BP >=20 mmHg or diastolic BP >=10 mmHg within 3 minutes of standing) within the past year or during screening, unrelated to medication changes; 8.Patient with sleep apnea requiring chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP), excluding nocturnal respiratory support only 9.Presence of primary pulmonary hypertension; 10.Patient with known causes of secondary hypertension (e.g., pheochromocytoma, Cushing's syndrome, aortic coarctation, untreated hyperthyroidism, or primary hyperparathyroidism); 11.History of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to screening, or presence of extensive atherosclerosis with intravascular thrombosis or unstable plaques; 12.Patient has scheduled or planned surgery or cardiovascular intervention within the next 6 months; 13.Patient has a condition that prohibits or interferes with accurate blood pressure measurement using the protocol-specified automated blood pressure monitor (e.g., excessive arm circumference preventing proper cuff fitting; arrhythmia interfering with the monitor's pulse sensing and accurate measurement); 14.Patient has severe cardiac valvular stenosis deemed by the investigator to contraindicate significant blood pressure reduction; 15.Patient has any severe concomitant disease considered by the investigator to potentially adversely affect participant safety and/or study efficacy (e.g., clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia); 16.Individual is pregnant, breastfeeding, or planning pregnancy. Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography; 17.Patient has a known, unresolved history of substance abuse or alcohol dependence, lacks the ability to understand or follow instructions, or is unlikely/unable to comply with study follow-up requirements; 18.Current participation in another interventional cl

Design outcomes

Primary

MeasureTime frame
office systolic blood pressure;Ambulatory blood pressure monitoring;urine protein;serum creatinine;

Secondary

MeasureTime frame
B-type natriuretic peptide;Renin;aldosterone;Renal Vascular CT Angiography (RV-CTA);HgbA1c;FBG(fasting blood-glucose);insulin;hCG;

Countries

China

Contacts

Public ContactYong Peng

The West China Hospital of Sichuan University

pengyongcd@126.com+86 189 8060 6696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026