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Angiotensin-Converting Enzyme (ACE) Inhibitor

Captopril for Myeloproliferative Neoplasms

Phase 1 & 2
Waitlist Available
Led By Aaron Gerds, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year from end of treatment
Awards & highlights

Study Summary

This trial is testing if captopril is safe and effective for treating people with myelofibrosis by reducing the grade of bone marrow scar tissue.

Eligible Conditions
  • Myeloproliferative Neoplasms
  • Bone Marrow Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year from end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year from end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in degree of bone marrow fibrosis by World Health Organization WHO grade
Secondary outcome measures
Change in spleen size by ultrasound
Change in symptom burden assessed using MPN-SAF TSS
Change in symptom burden assessed using Myeloproliferative Neoplasm Symptom Assessment Form total symptom scores (MPN-SAF TSS)
+1 more

Side effects data

From 2009 Phase 4 trial • 252 Patients • NCT00391846
9%
Cardiac Failure
4%
Myocardial Infarction
2%
Anaemia
2%
Angina Pectoris
2%
Artial Fibrillation
2%
Chronic Obstructive Pulmonary Disease
2%
Dyspnoea
2%
Hyperkalaemia
2%
Syncope
2%
Ventricular Tachycardia
2%
Pneumonia
1%
Cerebral Infarction
1%
Confusional State
1%
Multi-Organ Failure
1%
Cerebrovascular Accident
1%
Polymyalgia Rheumatica
1%
Hepatic Failure
1%
Spinal Fracture
1%
Back Pain
1%
Bladder Neoplasm
1%
Blood Electrolytes Abnormal
1%
Bradycardia
1%
Muscular Weakness
1%
Osteoarthritis
1%
Right Ventricular Failure
1%
Angina Unstable
1%
Aortic Stenosis
1%
B-Cell Lymphoma
1%
Bleeding Varicose Vein
1%
Bronchitis
1%
Carotid Artery Stenosis
1%
Concussion
1%
Diverticulitis
1%
Duodenal Ulcer Haemorrhage
1%
Dyspepsia
1%
Endocarditis
1%
Intervertebral Disc Compression
1%
Intestinal Ischaemia
1%
Pulmonary Odema
1%
Respiratory Tract Infection Viral
1%
Septic Shock
1%
Peripheral Ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guided by NT-proBNP
Not Guided by NT-proBNP

Trial Design

1Treatment groups
Experimental Treatment
Group I: CaptoprilExperimental Treatment1 Intervention
In phase I, Cohorts of 3 patients each will receive doses of captopril with a goal dose of 150mg total by mouth (PO) daily. Initial dose per patient will start at 12.5 mg daily, which will then be increased on weekly intervals as tolerated. To be administered per the intra-patient dose escalation scheme below Phase I: Day 0: 12.5mg/day Day 7: 12.5mg twice daily Day 14: 12.5mg three times daily Day 21: 25mg three times daily Day 28: 50mg three times daily Phase II: The efficacy of captopril will be assessed in the Phase II portion. Captopril given at Maximum Tolerated Dose - bone marrow evaluation to be done at 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Captopril
2017
Completed Phase 4
~530

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,354 Total Patients Enrolled
Aaron Gerds, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Media Library

Captopril (Angiotensin-Converting Enzyme (ACE) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04629651 — Phase 1 & 2
Myeloproliferative Neoplasms Research Study Groups: Captopril
Myeloproliferative Neoplasms Clinical Trial 2023: Captopril Highlights & Side Effects. Trial Name: NCT04629651 — Phase 1 & 2
Captopril (Angiotensin-Converting Enzyme (ACE) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629651 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participant count for this experiment?

"At this juncture, the study is not taking on additional patients. The medical trial was first uploaded in December 1st 2022 and last revised August 16th 2022. If you are searching for other trials, 2906 studies related to fibrosis are currently recruiting while 6 trials regarding Captopril still need participants."

Answered by AI

What medical conditions does Captopril most frequently serve to alleviate?

"Captopril has been observed to address the symptoms of ventricular dysfunction, left-sided heart failure, and diabetic nephropathy."

Answered by AI

Are there still opportunities for individuals to contribute to this research?

"The information listed on clinicaltrials.gov indicates that the recruitment process for this trial has been concluded, as of August 16th 2022. However, there are still 2912 other trials actively seeking applicants at present."

Answered by AI
~0 spots leftby Oct 2024