HypotensionNCT05051293
Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension
An observational study of Hypotension and Cirrhosis, run by Methodist Health System.
Trial summary
Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypotension, Cirrhosis
- What is being tested?
- serum concentration of estrogen (E1 and E2) and testosterone ratio measurement
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2021to 17 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients attending the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center, Dallas, Texas
Who may be able to join
- Male cirrhotic patients >18 years of age
- Patient must attend the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center
- willing to provide informed consent to participate in the study
Who cannot join
- Patients with a history of cirrhosis <18 years of age
- Cirrhosis patients with active infection
- Cirrhosis patients with active gastrointestinal bleeding
- Cirrhosis patients on hormone replacement therapy testosterone
- Cirrhosis patients on any antihypertensive medications
About this study
Official title: Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension
Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.
Read the detailed description
Another potential contributor to the development of hypotension in cirrhosis is thought to be due to the increased production of estrogen in males especially the estrone (E1) and estradiol (E2) concentration. The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. The increased estrogen concentration in cirrhosis patients results, in large part, from an increased peripheral conversion from androgens including testosterone. Previous studies have shown that increased estrogen concentration can cause a significant decrease in blood pressure in various cell, animal, and human models. Of note, estrogen has also been shown to enhance nitric oxide production in human beings.
- Conditions
- Hypotension, Cirrhosis
- Being tested
- serum concentration of estrogen (E1 and E2) and testosterone ratio measurement
- Medical subject headings
- Hypotension, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum concentration of estrogen (E1 and E2) and testosterone ratio measurementOther
To measure the serum concentration of estrogen (E1 and E2) and testosterone ratio in all male cirrhosis patients
| Study group | Role | What they receive |
|---|---|---|
| male cirrhotic with hypotension | Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. Receives: Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement | |
| male cirrhotic without hypotension | The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. Receives: Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum estrogen (E1 and E2) levels
Measurement of serum estrogen (E1 and E2) levels in cirrhotic males
Measured: July to September 2021
Serum testosterone levels
Measurement of serum testosterone levels in cirrhotic males
Measured: July to September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start22 Aug 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2024 (estimated)
Why it stopped: Study will be changed from prospective to retrospective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mangesh Pagadala, MD, Principal investigator, Methodist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051293
- Sponsor's protocol ID
- 097.HEP.2020.D
- Status last verified
- Aug 2023
- First submitted
- 10 Sep 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ge PS, Runyon BA. Treatment of Patients with Cirrhosis. N Engl J Med. 2016 Nov 24;375(21):2104-5. doi: 10.1056/NEJMc1612334. No abstract available.
PubMed 28121086Iwakiri Y, Groszmann RJ. The hyperdynamic circulation of chronic liver diseases: from the patient to the molecule. Hepatology. 2006 Feb;43(2 Suppl 1):S121-31. doi: 10.1002/hep.20993.
PubMed 16447289Cavanaugh J, Niewoehner CB, Nuttall FQ. Gynecomastia and cirrhosis of the liver. Arch Intern Med. 1990 Mar;150(3):563-5.
PubMed 2310274Gordon GG, Olivo J, Rafil F, Southren AL. Conversion of androgens to estrogens in cirrhosis of the liver. J Clin Endocrinol Metab. 1975 Jun;40(6):1018-26. doi: 10.1210/jcem-40-6-1018.
PubMed 1133151Seely EW, Walsh BW, Gerhard MD, Williams GH. Estradiol with or without progesterone and ambulatory blood pressure in postmenopausal women. Hypertension. 1999 May;33(5):1190-4. doi: 10.1161/01.hyp.33.5.1190.
PubMed 10334810
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension
- ClinicalTrials.gov ID
- NCT05051293
- Acronym / sponsor ID
- 097.HEP.2020.D
- Conditions
- Hypotension, Cirrhosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study will be changed from prospective to retrospective
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.
Detailed description
Another potential contributor to the development of hypotension in cirrhosis is thought to be due to the increased production of estrogen in males especially the estrone (E1) and estradiol (E2) concentration. The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. The increased estrogen concentration in cirrhosis patients results, in large part, from an increased peripheral conversion from androgens including testosterone. Previous studies have shown that increased estrogen concentration can cause a significant decrease in blood pressure in various cell, animal, and human models. Of note, estrogen has also been shown to enhance nitric oxide production in human beings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male cirrhotic with hypotension | – | Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurementPatients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. |
| male cirrhotic without hypotension | – | Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurementThe concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients attending the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center, Dallas, Texas
Key inclusion criteria (3 listed)
- Male cirrhotic patients >18 years of age
- Patient must attend the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center
- willing to provide informed consent to participate in the study
Key exclusion criteria (5 listed)
- Patients with a history of cirrhosis <18 years of age
- Cirrhosis patients with active infection
- Cirrhosis patients with active gastrointestinal bleeding
- Cirrhosis patients on hormone replacement therapy testosterone
- Cirrhosis patients on any antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum concentration of estrogen (E1 and E2) and testosterone ratio measurementTo measure the serum concentration of estrogen (E1 and E2) and testosterone ratio in all male cirrhosis patients | Other | male cirrhotic with hypotension, male cirrhotic without hypotension |
Primary outcome
Serum estrogen (E1 and E2) levels
Time frame: July to September 2021
Measurement of serum estrogen (E1 and E2) levels in cirrhotic males
Serum testosterone levels
Time frame: July to September 2021
Measurement of serum testosterone levels in cirrhotic males
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 28121086Ge PS, Runyon BA. Treatment of Patients with Cirrhosis. N Engl J Med. 2016 Nov 24;375(21):2104-5. doi: 10.1056/NEJMc1612334. No abstract available.
- Background: PubMed 16447289Iwakiri Y, Groszmann RJ. The hyperdynamic circulation of chronic liver diseases: from the patient to the molecule. Hepatology. 2006 Feb;43(2 Suppl 1):S121-31. doi: 10.1002/hep.20993.
- Background: PubMed 2310274Cavanaugh J, Niewoehner CB, Nuttall FQ. Gynecomastia and cirrhosis of the liver. Arch Intern Med. 1990 Mar;150(3):563-5.
- Background: PubMed 1133151Gordon GG, Olivo J, Rafil F, Southren AL. Conversion of androgens to estrogens in cirrhosis of the liver. J Clin Endocrinol Metab. 1975 Jun;40(6):1018-26. doi: 10.1210/jcem-40-6-1018.
- Background: PubMed 10334810Seely EW, Walsh BW, Gerhard MD, Williams GH. Estradiol with or without progesterone and ambulatory blood pressure in postmenopausal women. Hypertension. 1999 May;33(5):1190-4. doi: 10.1161/01.hyp.33.5.1190.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mangesh Pagadala, MD principal investigator
Methodist
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Cirrhosis, run by Methodist Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum estrogen (E1 and E2) levels (time frame: July to September 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051293, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.