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Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension

NCT06515678 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9464

Last updated 2024-07-26

No results posted yet for this study

Summary

Antiangiogenic therapies like bevacizumab, have notably improved cancer treatment, including for gynecological cancers, by inhibiting the vascular endothelial growth factor and thus limiting tumor growth. In treating advanced ovarian cancer, bevacizumab has been shown to extend progression-free survival by four months, though it also induces or worsens hypertension in 2 to 19% of patients by affecting vascular nitric oxide production or by capillary rarefaction. This hypertension may result in severe cardiovascular events, necessitating the use of antihypertensive drugs like calcium channel blockers and RAAS inhibitors (angiotensin converting enzyme - ACE - inhibitors mainly), despite some concerns about their effects on VEGF secretion and CA125 levels. Clinical guidelines vary, with some favoring ACE inhibitors while others recommend calcium channel blockers, underlining the need for comparative studies on these drugs' oncological and cardiovascular impacts. To address these issues, this study utilizes an emulated trial approach, leveraging comprehensive data from the French National Health Data System to compare the efficacy of these antihypertensive classes in reducing relapse and improving survival in ovarian cancer patients treated with bevacizumab.

The investigators will emulate a target clinical trial to compare the impact of antihypertensive treatments on outcomes of patients with bevacizumab-associated hypertension by ACE inhibitors (arm A) versus calcium channel blockers (CCBs, arm B) on the risk of ovarian cancer withdrawal after surgery.

Conditions

Interventions

DRUG

arm A - angiotensin converting enzyme inhibitors (ACEi)

Patients with ACEi monotherapy before or within 6 months following debulking surgery. ACEi will be defined as any drugs from the Anatomical Therapeutic Classification C09AA with an indication for hypertension, including but not limited to: captopril, enalapril, lisinopril, perindopril, ramipril, quinapril

DRUG

arm B - calcium channel blockers (CCBs)

Patients with CCB monotherapy before or within 6 months following debulking surgery. CCBs will be defined as any drugs from the Anatomical Therapeutic Classification C08CA with an indication for hypertension, including but not limited to: amlodipine, felodipine, isradipine, nicardipine, nifedipine

DRUG

arm R - angiotensin receptor blockers ARB

Patients with angiotensin receptor blocker (ARB) before or within 6 months following debulking surgery. ARBs will be defined as any drugs from the Anatomical Therapeutic Classification C09CA with an indication for hypertension, including but not limited to: losartan, valsartan, irbesartan, candesartan or olmesartan medoxomil.

Sponsors & Collaborators

  • Dr Floriane Jochum, Principal Investigator

    collaborator UNKNOWN

  • Institut Curie

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2024-08-01
Completion
2024-08-31
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515678 on ClinicalTrials.gov