Human Immunodeficiency VirusNCT03826160
Growth Hormone Dynamics and Cardiac Steatosis in HIV
An observational study of Human Immunodeficiency Virus and Lipodystrophy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 19 Apr 2022
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: HIV patients, age 40-70 years old, with abdominal fat accumulation
Who may be able to join
- Men and women, ages 40-70 years
- Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
- Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
- Indication for tesamorelin per clinical judgment
Who cannot join
- CD4 < 100 cells/mm3 or HIV viral load > 400 copies/mL
- Current active AIDS-defining illness
- History or symptoms consistent with heart failure
- Standard contraindications to MRI including severe allergy to gadolinium
- Glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 within one month of MRI study
- Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
Show all 10Show fewer
- HbA1c > 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
- Change in statin therapy within the past 3 months
- Chronic corticosteroid use except intermittent topic steroid creams or inhalers
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.
- Conditions
- Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Lipodystrophy, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tesamorelin | Individuals who plan to initiate tesamorelin clinically | |
| No Treatment | Individuals who decline to initiate tesamorelin despite a clinical indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramyocardial lipid content
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
Measured: 6 months
Secondary outcomes (1)
Circumferential diastolic strain rate
Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start30 Jan 2019
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826160
- Sponsor's protocol ID
- 2018P001792
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
- ClinicalTrials.gov ID
- NCT03826160
- Acronym / sponsor ID
- 2018P001792
- Conditions
- Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 1 Feb 2019 (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.
Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tesamorelin | – | –Individuals who plan to initiate tesamorelin clinically |
| No Treatment | – | –Individuals who decline to initiate tesamorelin despite a clinical indication |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- HIV patients, age 40-70 years old, with abdominal fat accumulation
Key inclusion criteria (4 listed)
- Men and women, ages 40-70 years
- Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
- Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
- Indication for tesamorelin per clinical judgment
Key exclusion criteria (10 listed)
- CD4 < 100 cells/mm3 or HIV viral load > 400 copies/mL
- Current active AIDS-defining illness
- History or symptoms consistent with heart failure
- Standard contraindications to MRI including severe allergy to gadolinium
- Glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 within one month of MRI study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intramyocardial lipid content
Time frame: 6 months
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
1 secondary outcome
Circumferential diastolic strain rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and Lipodystrophy, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intramyocardial lipid content (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2022.