HypertensionNCT01960946
Galectin-3 Blockade in Patients With High Blood Pressure
A study of Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 30 Aug 2018
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-70 years
- Physician diagnosed hypertension on stable therapy for 3 months
- Elevated galectin-3 level (above sex-specific median based on Framingham Heart Study measures)
- Able to understand the protocol and provide informed consent in English
Who cannot join
- Uncontrolled hypertension, defined as systolic blood pressure > 170mmHg, diastolic blood pressure > 100mmHg
- Evidence of secondary hypertension
- History of heart failure, coronary artery disease, stroke, atrial fibrillation
- Left ventricular ejection fraction < 45% on echocardiography
- Use of aldosterone antagonists
- History of liver cirrhosis
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- History of pulmonary fibrosis
- Kidney dysfunction, defined as estimated glomerular filtration rate < 45 ml/min/1.73m2
- Anemia, defined as hematocrit < 37% in men and < 34% in women
- Use of chelating agents
- History of Active cancer or malignancy
- Known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
- Hyperkalemia on screening labs, defined as potassium >5.2
- Anticipated inability to complete or comply with study protocol
- History of angioedema
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension
This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been deemed as 'generally regarded as safe' by the FDA.
This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood pressure. The study will help understand how MCP may affect the risk for heart disease in patients with high blood pressure.
Read the detailed description
Gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of clinical heart failure. In this study, we seek to identify individuals at risk for the development of heart failure based on clinical hypertension and elevated Gal-3 concentrations. Participants will be randomized to receive a Gal-3 inhibitor (MCP) or placebo. The primary outcome will be the effect on collagen metabolism, and secondary outcomes include echocardiographic measures of cardiac structure and function, and non-invasive measures of vascular function.
- Conditions
- Hypertension
- Being tested
- Modified Citrus Pectin (MCP) vs placebo
- Keywords
- Hypertension, Galectin 3, Fibrosis, Vascular Stiffness, Echocardiography
- Medical subject headings
- Hypertension, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Citrus Pectin (MCP) vs placeboDietary supplement
Also called MCP, PectaSol-C
5 grams by mouth three times a day
| Study group | Role | What they receive |
|---|---|---|
| Modified Citrus Pectin (MCP) | Active comparator | Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day Receives: Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo |
| Placebo | Placebo comparator | Matched placebo 5 grams by mouth three times a day Receives: Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in markers of collagen metabolism
Primary aim will be change in markers of collagen metabolism (PICP, PIIICP, ICTP, TIMP-1) in MCP versus placebo groups over 6 months of treatment.
Measured: Baseline and 6 months
Secondary outcomes (3)
Change in galectin-3 level
Changes in galectin-3 level from baseline until 6 months will be compared between MCP and placebo groups
Measured: Baseline and 6 months
Changes in cardiac structure and function
Changes in cardiac structure and function will be examined using 2-D echocardiography and tissue Doppler imaging. This will include changes in left ventricular mass, dimensions, left atrial size, and left ventricular diastolic function.
Measured: Baseline and 6 months
Changes in arterial stiffness
We will examine changes in arterial stiffness (including augmentation index, carotid-femoral pulse-wave velocity) from baseline to 6 months in the MCP and placebo groups
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jennifer En-Sian Ho M.D., Massachusetts General Hospital
- Investigators
- Jennifer E Ho, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960946
- Sponsor's protocol ID
- 2015P0023402
- Other IDs
- K23HL116780
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2013
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lau ES, Liu E, Paniagua SM, Sarma AA, Zampierollo G, Lopez B, Diez J, Wang TJ, Ho JE. Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension. JACC Basic Transl Sci. 2021 Jan 6;6(1):12-21. doi: 10.1016/j.jacbts.2020.10.006. eCollection 2021 Jan.
PubMed 33532663
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension
- ClinicalTrials.gov ID
- NCT01960946
- Acronym / sponsor ID
- 2015P0023402
- Conditions
- Hypertension
- Keywords
- Hypertension, Galectin 3, Fibrosis, Vascular Stiffness, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2013
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 11 Oct 2013 (estimated)
- 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.
This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been deemed as 'generally regarded as safe' by the FDA.
This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood pressure. The study will help understand how MCP may affect the risk for heart disease in patients with high blood pressure.
Detailed description
Gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of clinical heart failure. In this study, we seek to identify individuals at risk for the development of heart failure based on clinical hypertension and elevated Gal-3 concentrations. Participants will be randomized to receive a Gal-3 inhibitor (MCP) or placebo. The primary outcome will be the effect on collagen metabolism, and secondary outcomes include echocardiographic measures of cardiac structure and function, and non-invasive measures of vascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Citrus Pectin (MCP) | Active comparator | Dietary Supplement: Modified Citrus Pectin (MCP) vs placeboDietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day |
| Placebo | Placebo comparator | Dietary Supplement: Modified Citrus Pectin (MCP) vs placeboMatched placebo 5 grams by mouth three times a day |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-70 years
- Physician diagnosed hypertension on stable therapy for 3 months
- Elevated galectin-3 level (above sex-specific median based on Framingham Heart Study measures)
- Able to understand the protocol and provide informed consent in English
Key exclusion criteria (15 listed)
- Uncontrolled hypertension, defined as systolic blood pressure > 170mmHg, diastolic blood pressure > 100mmHg
- Evidence of secondary hypertension
- History of heart failure, coronary artery disease, stroke, atrial fibrillation
- Left ventricular ejection fraction < 45% on echocardiography
- Use of aldosterone antagonists
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 |
|---|---|---|
| Modified Citrus Pectin (MCP) vs placeboAlso: MCP, PectaSol-C5 grams by mouth three times a day | Dietary supplement | Modified Citrus Pectin (MCP), Placebo |
Primary outcome
Change in markers of collagen metabolism
Time frame: Baseline and 6 months
Primary aim will be change in markers of collagen metabolism (PICP, PIIICP, ICTP, TIMP-1) in MCP versus placebo groups over 6 months of treatment.
3 secondary outcomes
Change in galectin-3 level
Time frame: Baseline and 6 months
Changes in cardiac structure and function
Time frame: Baseline and 6 months
Changes in arterial stiffness
Time frame: Baseline and 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 21 Feb 2021.
- Results publication: PubMed 33532663Lau ES, Liu E, Paniagua SM, Sarma AA, Zampierollo G, Lopez B, Diez J, Wang TJ, Ho JE. Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension. JACC Basic Transl Sci. 2021 Jan 6;6(1):12-21. doi: 10.1016/j.jacbts.2020.10.006. eCollection 2021 Jan.
- 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.
Jennifer E Ho, 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?
A study of Hypertension, 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 15 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 21 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Change in markers of collagen metabolism (time frame: Baseline and 6 months). 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 NCT01960946, which also lists 1 linked publication.
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 21 Feb 2021.